stay.safe®

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Holdings, Inc.

Identity

Trade Name: stay.safe® FDA UDI
Generic Name: Peritoneal dialysis system tubing set FDA UDI
Device Name: stay.safe® Catheter Extension Set with Luer-Lock, 12 inch FDA UDI
Model / Reference: 050-95004 FDA UDI
Description: stay.safe® Catheter Extension Set with Luer-Lock, 12 inch FDA UDI

Identifiers

Primary DI / UDI-DI: 00840861100781 FDA UDI
FDA Product Code: KDJ FDA UDI
GMDN Term: Peritoneal dialysis system tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5630 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

Yes

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

Category: Peritoneal dialysis system tubing set

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

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Also classified as Peritoneal dialysis system tubing set.

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UltraSet CAPD Disposable Disconnect Y-Set — BAXTER INTERNATIONAL INC. · Class II
HOMECHOICE APD SET — BAXTER INTERNATIONAL INC. · Class II
MiniCap — Baxter Healthcare Corp · Class II
Extension Set — BAXTER INTERNATIONAL INC. · Class II

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 6d488598-e5cf-4341-ae57-5f7f305805ef 34 fields · synced Jun 1, 2026