← Back to catalogue

Tenckhoff

FDA UDI

Class I (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Tenckhoff FDA UDI
Generic Name
Peritoneal dialysis catheter, acute FDA UDI
Device Name
Tenckhoff Acute Peritoneal Dialysis Catheter Set Silicone Catheter With 11Fr Peel-Away Introducer Set FDA UDI
Model / Reference
G09085 FDA UDI
Description
Tenckhoff Acute Peritoneal Dialysis Catheter Set Silicone Catheter With 11Fr Peel-Away Introducer Set FDA UDI

Identifiers

Catalog Number
C-TAPS-9.5-31-12-0-10.5 FDA UDI
Primary DI / UDI-DI
00827002090859 FDA UDI
FDA Product Code
GBW FDA UDI
GMDN Term
Peritoneal dialysis catheter, acute FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Peritoneal dialysis catheter, acute

Tenckhoff by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal dialysis catheter, acute.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 9a8d5150-f487-4a45-b394-0e74899d98a7 36 fields · synced Jun 8, 2026