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Pm007

FDA UDI

Class II (US FDA UDI)

by Pathen Medical Llc

Identity

Trade Name
PM007 FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
7" Macro Bore, extenstion set with pinch clamp FDA UDI
Model / Reference
PM007 FDA UDI
Description
7" Macro Bore, extenstion set with pinch clamp FDA UDI

Identifiers

Primary DI / UDI-DI
00850005864530 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Intravenous administration tubing extension set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intravenous administration tubing extension set

Pm007 by Pathen Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravenous administration tubing extension set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pathen Medical Llc

Sources (1)

  • FDA UDI fbce7979-1e0c-4116-87a3-b02e5329e14a 34 fields · synced May 30, 2026