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Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Arterial blood pressure catheter FDA UDI
Device Name
Arterial Line Kit with Sharps Safety Features FDA UDI
Model / Reference
IPN034369 FDA UDI
Description
Arterial Line Kit with Sharps Safety Features FDA UDI

Identifiers

Catalog Number
ASK-04510-HF FDA UDI
Primary DI / UDI-DI
00801902045881 FDA UDI
510(k) Number
K810675 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Arterial blood pressure catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 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

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

No

FDA UDI

Category: Arterial blood pressure catheter

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

Similar devices

Also classified as Arterial blood pressure catheter.

Cleared under the same submission

K810675 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 5413e28c-fd80-461d-8b5c-66f9d29b0073 36 fields · synced May 30, 2026