Churchill Medical Systems

Lot Numbers: 10I60, 10K42 and 10F87.

General Hospital and Personal Use Devices

Unclassified

No

United States (FL, MA, MD, and VA).

Churchill Medical Systems || AMS-8316CP-1 (Central Line Dressing Kit). || The device intended use is a central line dressing kit.

Lot Number: 10H30.

General Hospital and Personal Use Devices

Unclassified

No

United States (FL, MA, MD, and VA).

Churchill Medical Systems AMS-8431CP (PICC insertion Tray). || The device intended use is a PICC insertion tray.

AMS-9189CP-1, Lot Numbers: 1006150, 1006149 and 1008143. AMS-9189CP, Lot Number: 1003527.

General Hospital and Personal Use Devices

Unclassified

No

United States (FL, MA, MD, and VA).

Churchill Medical Systems || AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. || Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. || The devices intended use is a Dressing Change Kit.

Lot Number: 1202077

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) including states of: IN, KS, KY, NY,MA, MI , and TX; and country of: Canada.

Churchill Medical Systems Winged Infusion Set, 22Ga, 1", || Latex-Free Winged Infusion Set || Product Code: MBS-2210 || Huber type needle set used for the infusion of medical fluids into implantable ports.

Product Code AMS-9848CP-11 -- lots 10J80 and 10K62.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit || Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens