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Pmi

FDA UDI

Class II (US FDA UDI)

by Progressive Medical, Inc.

Identity

Trade Name
PMI FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
PMI IV admin set with flow regulator and needle-free y-site approx. 11" from distal end, 100" length, 20 drop, 15 micron filter in drip chamber, rotating male luer lock, vented cap, pinch clamp FDA UDI
Model / Reference
PMIFR200 FDA UDI
Description
PMI IV admin set with flow regulator and needle-free y-site approx. 11" from distal end, 100" length, 20 drop, 15 micron filter in drip chamber, rotating male luer lock, vented cap, pinch clamp FDA UDI

Identifiers

Catalog Number
PMIFR200 FDA UDI
Primary DI / UDI-DI
00812608021833 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

No

FDA UDI

Category: Intravenous administration tubing extension set

Pmi by Progressive Medical, Inc. — 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
Progressive Medical, Inc.

Sources (1)

  • FDA UDI 34aa2d82-2523-423d-8147-c45b95b156af 35 fields · synced Jun 6, 2026