Namic

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: NAMIC FDA UDI
Generic Name: Radiographic procedure tubing FDA UDI
Device Name: High Pressure Contrast Injection Line FDA UDI
Model / Reference: 91001203 FDA UDI
Description: High Pressure Contrast Injection Line FDA UDI

Identifiers

Primary DI / UDI-DI: H965910012030 FDA UDI
510(k) Number: K822100 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: Pressure — 1000 Pound per Square Inch FDA UDI
Length — 20 Inch FDA UDI

Category: Radiographic procedure tubing

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

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Also classified as Radiographic procedure tubing.

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

Cleared under the same submission

K822100 also covers:

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: Navilyst Medical, Inc.

Sources (1)

FDA UDI 51186ebc-8836-45b0-b11e-a6324b9d52bc 36 fields · synced Jun 1, 2026