LIifeShield CLAVE

  • 모델명 / 제조번호(시리얼번호)
    ***** CANADA DISTRIBUTION *****   *** 1) List Number 14220-28-01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (Nationwide) Distribution
  • 제품 설명
    *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    ***** US DISTRIBUTION *****   *** 1) List Number: 14212-04-28; Lot Numbers:  962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ;  *** 2) List Number: 14254-08-28; Lot Number:  072055H;  *** 3) List Number: 14687-04-28; Lot Numbers:  650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , 171435H , 180405H , 211275H , 201225H , 201235H ;    ***** FOREIGN DISTRIBUTION *****   *** 4) List Number: 12193-83-24; Lot Numbers:  662095H , 712345H , 741615H , 880705H , 890735H , 920595H , 952665H , 020485H ;  *** 5) List Number: 12193-92-28; Lot Numbers:  063285H , 071115H , 071475H , 133335H , 140205H , 171535H , 180045H , 250515H , 281895H ;  *** 6) List Number: 19194-83-24; Lot Numbers:  662115H , 702305H , 721795H , 721805H , 732055H , 732035H , 732045H , 732065H ;  *** 7) List Number: 19194-84-24; Lot Numbers:  881945H,  950975H;  *** 8) List Number: 12194-92-28; Lot Numbers:  071105H , 140085H , 151445H , 180055H ;  *** 9) List Number: 12195-83-24; Lot Numbers:  662105H , 712355H , 821545H , 880715H , 890745H , 910745H ;  *** 10) List Number: 12195-84-24; Lot Numbers:  681645H , 681655H , 702295H , 721695H , 721785H , 741635H , 741355H , 761495H , 771395H , 782265H , 782275H , 791315H , 890755H , 900455H , 940615H , 951325H , 010725H , 011475H , 020895H , 021415H ;  *** 11) List Number: 12195-92-28; Lot Numbers:  063185H , 063195H , 071125H , 102395H , 102405H , 111705H , 111715H , 113055H , 112865H , 131865H , 133405H , 140115H , 153385H , 162385H , 171445H , 180065H , 180075H , 200855H , 210865H , 201895H , 221315H , 250525H , 260235H , 271645H , 270825H ;  *** 12) List Number: 12196-83-24; Lot Numbers:  662125H , 702315H , 702325H , 712245H , 712255H ;  *** 13) List Number: 12196-84-24; Lot Number:  871295H;  *** 14) List Number: 12196-92-28; Lot Numbers:  071135H , 131835H , 151545H , 211645H , 250505H , 281575H ;  *** 15) List Number: 14001-07-28; Lot Numbers:  810195H , 810205H , 831395H , 830775H , 890985H , 902085H , 220125H ;  *** 16) List Number: 14001-82-28; Lot Numbers:  890945H , 932935H , 151585H ;  *** 17) List Number: 14001-83-28; Lot Numbers:  752235H , 851525H , 871535H , 890765H , 900465H , 910215H , 951335H , 960405H , 010735H , 010755H , 020905H , 032185H , 040965H , 053775H , 061775H ;  *** 18) List Number: 14001-84-28; Lot Numbers:  752254H , 830785H , 851515H , 890775H , 950355H ;  *** 19) List Number: 14001-92-28; Lot Numbers:  063255H , 081605H , 081615H , 091115H , 161615H , 162365H , 180395H , 190925H , 220155H , 190935H , 190945H ;  *** 20) List Number: 14007-82-01; Lot Numbers:  811595H,  160345H;  *** 21) List Number: 14007-92-28; Lot Numbers:  251485H,  270875H;  *** 22) List Number: 14009-82-01; Lot Numbers:  811525H,  840885H,  910095H;  *** 23) List Number: 14011-82-01; Lot Number:  811555H;  *** 24) List Number: 14012-92-28; Lot Numbers:  162315H,  231615H;  *** 25) List Number: 14013-82-01; Lot Numbers:  811535H,  840895H,  920855H;  *** 26) List Number: 14014-92-28; Lot Number:  162305H;  *** 27) List Number: 14015-82-01; Lot Numbers:  811515H,  910105H;  *** 28) List Number: 14017-82-01; Lot Number:  811705H;  *** 29) List Number: 14017-92-28; Lot Numbers:  112855H,  200955H;  *** 30) List Number: 14022-92-28; Lot Numbers:  162325H,  172265H;  *** 31) List Number: 14212-92-28; Lot Numbers:  071955H , 091685H , 100885H , 110505H , 113655H , 143425H , 161415H ;  *** 32) List Number: 19673-53-24; Lot Numbers:  662035H , 701715H , 721575H , 910115H , 910515H , 961555H , 011455H , 031335H , 061995H , 102145H , 111615H , 132705H , 180615H , 201815H , 220725H , 200275H , 241365H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (Nationwide) Distribution
  • 제품 설명
    *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; || *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; || Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ***** US DISTRIBUTION *****  *** 1) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ;  *** 2) List Number: 14954-04-28; Lot Numbers:  662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ;  *** 3) List Number: 19553-04-12; Lot Number:  751145H;  *** 4) List Number: 19556-04-28; Lot Numbers:  750295H , 801115H , 900585H , 040145H , 143175H , 210195H , 281095H ;  *** 5) List Number: 19557-04-28; Lot Numbers:  962435H , 040155H , 070705H , 071735H , 082165H , 091245H , 091255H , 091365H , 102515H , 200795H , 200945H , 210835H , 241705H , 280465H , 280475H , 240135H ;  *** 6) List Number: 19671-04-28; Lot Numbers:  701785H , 730805H , 811605H , 861435H , 880255H ;  *** 7) List Number: 19683-04-28; Lot Numbers:  782315H , 042125H , 211065H , 231825H ;  *** 8) List Number: 19685-04-28; Lot Numbers:  682285H , 791285H , 850175H ;  *** 9) List Number: 19720-04-28; Lot Numbers:  962305H , 092585H , 121635H , 180645H , 221715H , 260525H ;  *** 10) List Number: 19721-04-28; Lot Numbers:  962315H,  132735H;  *** 11) List Number: 19729-04-28; Lot Numbers:  032195H , 082285H , 121645H , 170415H , 200235H ;  *** 12) List Number: 19734-04-28; Lot Number:  133265H;   ***** CANADA DISTRIBUTION *****   *** 13) List Number: 14951-04-48; Lot Numbers:  761875H , 761905H , 821525H , 830335H , 870625H , 870635H , 880125H , 051955H , 092565H , 142995H , 211715H , 231355H , 271495H , 281105H ;  *** 14) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ;  *** 15) List Number: 14954-04-28; Lot Numbers:  662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ;  *** 16) List Number: 19732-04-28; Lot Numbers:  114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (Nationwide) Distribution
  • 제품 설명
    *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; || *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; || *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** || 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; || *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; || *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; || *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; || *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; || *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; || *** 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; || *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; || Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ***** US DISTRIBUTION *****  *** 1) List Number: 19734-04-28; Lot Number:  133265H;   ***** CANADA DISTRIBUTION *****   *** 1) List Number: 19732-04-28; Lot Numbers:  114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (Nationwide) Distribution
  • 제품 설명
    *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; || Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (Nationwide) Distribution
  • 제품 설명
    *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; || *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; || *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; || *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: || *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; || *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; || Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer