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Asept

FDA UDI

Class II (US FDA UDI)

by Pfm Medical Incorporated

Identity

Trade Name
ASEPT FDA UDI
Generic Name
Pleural drainage valve FDA UDI
Device Name
ASEPT Replacement Valve FDA UDI
Model / Reference
M7004 FDA UDI
Description
ASEPT Replacement Valve FDA UDI

Identifiers

Catalog Number
M7004 FDA UDI
Primary DI / UDI-DI
00813623017047 FDA UDI
510(k) Number
K093796 FDA UDI
FDA Product Code
PNG FDA UDI
GMDN Term
Pleural drainage valve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 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: Pleural drainage valve

Asept by Pfm Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pleural drainage valve.

Cleared under the same submission

K093796 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pfm Medical Incorporated

Sources (1)

  • FDA UDI a06b6fc7-6af7-43b5-b471-a15d1a47d089 36 fields · synced May 30, 2026