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Asept

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
ASEPT FDA UDI
Generic Name
Peritoneal drainage catheter FDA UDI
Device Name
ASEPT PERITONEAL DRAINAGE SYSTEM FDA UDI
Model / Reference
622284 FDA UDI
Description
ASEPT PERITONEAL DRAINAGE SYSTEM FDA UDI

Identifiers

Catalog Number
622284 FDA UDI
Primary DI / UDI-DI
04046964317330 FDA UDI
510(k) Number
K093796 FDA UDI
K221779 FDA UDI
FDA Product Code
PNG FDA UDI
GMDN Term
Peritoneal drainage catheter 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: Peritoneal drainage catheter

Asept by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal drainage catheter.

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
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI 030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd 37 fields · synced May 30, 2026