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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
Large Volume Abdominal Paracentesis Kit FDA UDI
Model / Reference
IPN036694 FDA UDI
Description
Large Volume Abdominal Paracentesis Kit FDA UDI

Identifiers

Catalog Number
ASK-00376-SU FDA UDI
Primary DI / UDI-DI
10801902120189 FDA UDI
510(k) Number
K874063 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Pleural/peritoneal drainage catheterization kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe 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

K874063 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 d418ce33-0b9b-42ef-8601-95a094acea65 37 fields · synced Jun 8, 2026