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ASEPT Pleural Drainage System

FDA UDI

Class II (US FDA UDI)

by Pfm Medical Incorporated

Identity

Trade Name
ASEPT Pleural Drainage System FDA UDI
Generic Name
Pleural drainage system FDA UDI
Device Name
ASEPT Pleural Drainage System FDA UDI
Model / Reference
M7031 FDA UDI
Description
ASEPT Pleural Drainage System FDA UDI

Identifiers

Catalog Number
M7031 FDA UDI
Primary DI / UDI-DI
00813623011359 FDA UDI
FDA Product Code
DWM FDA UDI
GMDN Term
Pleural drainage system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5050 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

Yes

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 system

ASEPT Pleural Drainage System by Pfm Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pleural drainage system.

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 a7d4a9b6-8049-433d-b566-41510ea06c01 35 fields · synced May 30, 2026