Coeur

FDA UDI

Class II (US FDA UDI)

by Coeur, Inc.

Identity

Trade Name: Coeur FDA UDI
Generic Name: Radiographic procedure tubing FDA UDI
Device Name: 72 in. (1828mm) High Pressure Line with Rotating Adapter FDA UDI
Model / Reference: C403-0721 FDA UDI
Description: 72 in. (1828mm) High Pressure Line with Rotating Adapter FDA UDI

Identifiers

Catalog Number: C403-0721 FDA UDI
Primary DI / UDI-DI: M297307210 FDA UDI
510(k) Number: K071196 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Radiographic procedure tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 1828 Millimeter FDA UDI
Length — 72 Inch FDA UDI

Category: Radiographic procedure tubing

Coeur by Coeur, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K071196 also covers:

Coeur — Coeur, Inc.
Coeur — Coeur, Inc.
Coeur — Coeur, Inc.
Coeur — Coeur, Inc.
Coeur — Coeur, Inc.
Coeur/Nemoto — Coeur, Inc.
Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Coeur, Inc.

Sources (1)

FDA UDI 4b588bae-fc65-4000-b8e5-2c0b44be4249 37 fields · synced Jun 7, 2026