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Fk20215e

FDA UDI

Class II (US FDA UDI)

by Pathen Medical Llc

Identity

Trade Name
FK20215E FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
5” (13cm) Tri-fuse Minibore extension set with 3 slide clamps male luer lock and 3 non-bonded needle-free connectors FDA UDI
Model / Reference
FK20215E FDA UDI
Description
5” (13cm) Tri-fuse Minibore extension set with 3 slide clamps male luer lock and 3 non-bonded needle-free connectors FDA UDI

Identifiers

Primary DI / UDI-DI
00850005864172 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

Fk20215e 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 9ae9e70f-7ec3-4042-a8b2-d34a12c6d5ac 34 fields · synced May 30, 2026