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Pme007hpb

FDA UDI

Class II (US FDA UDI)

by Pathen Medical Llc

Identity

Trade Name
PME007HPB FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
7" Microbore extension set with pinch clamp male luer lock with non-bonded needle-free connector, Purple PINCH clamp High Pressure (Sterile Packaging) BONDED FDA UDI
Model / Reference
PME007HPB FDA UDI
Description
7" Microbore extension set with pinch clamp male luer lock with non-bonded needle-free connector, Purple PINCH clamp High Pressure (Sterile Packaging) BONDED FDA UDI

Identifiers

Primary DI / UDI-DI
00850005864431 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

Pme007hpb 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 ccca6529-8922-4e94-ae60-15287ddd8b00 34 fields · synced May 30, 2026