Nxstage Tpe Cartridge

FDA UDI

Class U (US FDA UDI)

by NxStage Medical, Inc.

Identity

Trade Name: NXSTAGE TPE CARTRIDGE FDA UDI
Generic Name: Apheresis system tubing set FDA UDI
Model / Reference: CAR-510-C FDA UDI

Identifiers

Primary DI / UDI-DI: M535CAR510C0 FDA UDI
FDA Product Code: LKN FDA UDI
KDI FDA UDI
GMDN Term: Apheresis system tubing set FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 876.5860 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: Apheresis system tubing set

Nxstage Tpe Cartridge by NxStage Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 U	Pending data

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Manufacturer

Manufacturer: NxStage Medical, Inc.

Sources (1)

FDA UDI 0ec5be74-c439-426f-907d-22a2ac9f10a5 33 fields · synced Jun 9, 2026