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FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Pleural/peritoneal drainage catheterization kit FDA UDI
Device Name
Peritoneal Lavage Kit FDA UDI
Model / Reference
IPN032636 FDA UDI
Description
Peritoneal Lavage Kit FDA UDI

Identifiers

Catalog Number
AK-09001 FDA UDI
Primary DI / UDI-DI
00801902111432 FDA UDI
510(k) Number
K811627 FDA UDI
FDA Product Code
GBW FDA UDI
GMDN Term
Pleural/peritoneal drainage catheterization kit 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

Yes

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/peritoneal drainage catheterization kit

Arrow by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pleural/peritoneal drainage catheterization kit.

Cleared under the same submission

K811627 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI b6c97bd6-88b8-4c87-817c-c38086a6acb5 36 fields · synced May 30, 2026