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Arterial Line Pack

FDA UDI

Class I (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name
Arterial Line Pack FDA UDI
Generic Name
Angiography kit FDA UDI
Device Name
Arterial Line Pack FDA UDI
Model / Reference
498415C FDA UDI
Description
Arterial Line Pack FDA UDI

Identifiers

Catalog Number
498415C FDA UDI
Primary DI / UDI-DI
00886333215683 FDA UDI
510(k) Number
K780871 FDA UDI
FDA Product Code
GDY FDA UDI
GMDN Term
Angiography kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4450 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

Arterial Line Pack by Argon Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K780871 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (1)

  • FDA UDI 6e5d5085-6076-48a9-8d4e-5757d500812f 37 fields · synced Jun 9, 2026