ASEPT Peritoneal Drainage System

FDA UDI

Class I (US FDA UDI)

by Pfm Medical Incorporated

Identity

Trade Name: ASEPT Peritoneal Drainage System FDA UDI
Generic Name: Peritoneal drainage catheter FDA UDI
Device Name: ASEPT Drainage Bag with Procedure Pack FDA UDI
Model / Reference: M7060 FDA UDI
Description: ASEPT Drainage Bag with Procedure Pack FDA UDI

Identifiers

Catalog Number: M7060 FDA UDI
Primary DI / UDI-DI: 00813623014220 FDA UDI
510(k) Number: K093796 FDA UDI
FDA Product Code: FMH FDA UDI
GMDN Term: Peritoneal drainage catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Peritoneal drainage catheter

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

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Cleared under the same submission

K093796 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Pfm Medical Incorporated

Sources (1)

FDA UDI 96293d00-2b52-4e1d-bb80-b3b284e4374c 36 fields · synced May 30, 2026