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Atellica® VTR Syringes

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name
Atellica® VTR Syringes FDA UDI
Generic Name
Arterial blood sampling kit FDA UDI
Device Name
3mL Vented Luer Lock Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label) FDA UDI
Model / Reference
11561345 FDA UDI
Description
3mL Vented Luer Lock Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label) FDA UDI

Identifiers

Primary DI / UDI-DI
00709078013386 FDA UDI
510(k) Number
K822786 FDA UDI
FDA Product Code
CBT FDA UDI
GMDN Term
Arterial blood sampling kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.1100 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Arterial blood sampling kit

Atellica® VTR Syringes by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arterial blood sampling kit.

Cleared under the same submission

K822786 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA UDI 1bfcff26-3f84-4f04-ac7d-966ff6db90d4 34 fields · synced May 30, 2026