Baxter Healthcare Corporation

UDI: 00085412475813 Lot numbers: 802284, 802285, 802286

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Distribution

Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 || Usage: || Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475806 Lot Numbers: 802282, 802283

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Distribution

Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 || Usage: || Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Distribution

Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 || Usage: || Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Distribution

Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 || Product Usage: || Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

All Lots and Serial Numbers

Gastroenterology-Urology Devices

2

No

Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.

Prismaflex 7.20 US, Product Code 955542 || Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.