ARROWgard Blue(R) MAC(TM) TwoLumen Central Venous Access Ki

510K # K002507, Material # ASK-21142-HF3

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters || The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Lot Numbers: (1) 13F16L0254, 13F17B0196, 13F17C0046; (2) 13F17D0212, 13F17E0770, 13F17F0438; (3) 13F17E0656, 13F17F0188, 13F17F0459; (4) 13F17B0139, 13F17B0140, 13F17B0141, 13F17B0142, 13F17D0131, 13F17D0141, 13F17E0509, 13F17E0510, 13F17E0867, 13F17F0439; (5) 13F17C0339, 13F17E0230, 13F17E0718; (6) 13F16L0179, 13F17E0042, 13F17E0231, 13F17E0411, 13F17E0836

General Hospital and Personal Use Devices

2

No

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A