Fresenius

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Holdings, Inc.

Identity

Trade Name: Fresenius FDA UDI
Generic Name: Haemodialysis blood tubing set, single-use FDA UDI
Device Name: Prime Bags, 2-Liter, bulk pack FDA UDI
Model / Reference: 04-9300-7 FDA UDI
Description: Prime Bags, 2-Liter, bulk pack FDA UDI

Identifiers

Catalog Number: 04-9300-7 FDA UDI
Primary DI / UDI-DI: 10840861100535 FDA UDI
510(k) Number: K962081 FDA UDI
FDA Product Code: FJK FDA UDI
GMDN Term: Haemodialysis blood tubing set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 2 Liter FDA UDI

Category: Haemodialysis blood tubing set, single-use

Fresenius by Fresenius Medical Care Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis blood tubing set, single-use.

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5008X — Fresenius Medical Care Renal Therapies Group, LLC · Class II
NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATION · Class II
Nipro Set Blood Tubing Set — NIPRO MEDICAL CORPORATION · Class II
Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Lifemed Low Volume Tubing Set — Lifemed of California · Class II

Cleared under the same submission

K962081 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fresenius Medical Care Holdings, Inc.

Sources (1)

FDA UDI 2bafb0a1-001c-4f8f-93c8-127f655352a7 37 fields · synced May 29, 2026