Replacement Gastrostomy Device

Lot Numbers: HUSD1960 and HUSD1959.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.

Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. || The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

Lot numbers: HUSD0118, HUSD1610 and HUSD0116.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.

Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. || The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

Lot Numbers: HUSD1611, HUSD1963, HUSD0119, HUSD0120 and HUSD1962.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.

Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. || The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

43AOA018, 43AOA041, 43APA032, 43BOA015, 43BOA037, 43BPA025,  43BQA042, 43BQA184, 43COA013, 43COA036, 43CQA232, 43DOA010,  43DOA037, 43DPAO14, 43DQA063, 43EOA0 13, 43EOA041, 43EPAO13, 43EPA040, 43FOA076, 43FOA107, 43FOA234, 43GOA033, 43GOA009,  43GPA177R, 43GPA178R, 43GPA190R, 43GPA195R, 43HOA031,  43HPA018, 43HPA050, 43HPA223R, 43INA031, 43IOA038, 43IPA017R,  43IPA207R, 43IQA001, 43JNAOO1, 43JNAO44, 43JNA203, 43JNA219,  43JOA014, 43JPA013, 43JPA036, 43KNA012, 43KNA053, 43KOA016,  43KPA013, 43LNAO22, 43LNAO52, 43LOA023, 43LQA001, HURB2525,  HURB3526, HURD1915, HURF0483, HURG1443, HURH1078,  HURJ0571, HURB2422, HURD0734, HURE0535, HURE2889, HURG1444,  and HURJ0594.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.

Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. || Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. || The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.

43AOA019,  43LNA053,  43AOA042,  43LOA024,  43APA033,  43LPA008,  43ARAOO2,  43LQAO29,  HURA1265,  43BOA016,  HURB2526,  43BOA038,  HURB4356,  43BQA043,  HURB4357,  43COA014,  HURD1917,  43COA037,  HURF0484,  43DOA011,  HURG1445,  HURH1079,  HURJ0002,  43DOA038,  43DOA203,  43DPA015,  HURJ0595,  43DPA044,  HURJ1549,  43DPA204,  HURK1491,  43DPA205,  HURB2425,  43DQA064,  HURB4421,  43EOA014,  HURD1916,  43EOA042,  HURE2890,  43EPA014,  HURF0485,  43EPAO41,  HURH0242,  43EPA209,  HURH1080,  43EPA216,  HURJ1557,  43EQA009,  43FOA077,  43FOA108,  43GOA034, 43GPA179R,  43GPA180R,  43GQA001,  43GQA032,  43HPA019R, 43HPA192,  43HPA225R,  43HQA001,  43HQA165,  43INA032,  43IOA039,  43IPAO18,  43IPA041,  43IPA199R,  43IQA002,  43JNA002,  43JNA045,  43JNA204,  43JOA015,  43JPA014,  43JPA037,  43JQA001,  43JQA027,  43KPA014,  43KQA001,  43KQA027, and  43LNA023.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.

Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. || Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. || The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.