← Back to catalogue

Contrast Line

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name
Contrast Line FDA UDI
Generic Name
Radiographic procedure tubing FDA UDI
Device Name
Contrast Line 20"(50cm) Male/Female PVC 1200 PSI FDA UDI
Model / Reference
193351 FDA UDI
Description
Contrast Line 20"(50cm) Male/Female PVC 1200 PSI FDA UDI

Identifiers

Catalog Number
193351 FDA UDI
Primary DI / UDI-DI
00886333207350 FDA UDI
510(k) Number
K963749 FDA UDI
FDA Product Code
DTL FDA UDI
GMDN Term
Radiographic procedure tubing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4290 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Contrast Line by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K963749 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (1)

  • FDA UDI e1a140ac-459d-451e-b529-14b921a05553 38 fields · synced Jun 9, 2026