Namic

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: NAMIC FDA UDI
Generic Name: Angiographic syringe FDA UDI
Device Name: Polycarbonate Syringe 6mL FDA UDI
Model / Reference: 70127462 FDA UDI
Description: Polycarbonate Syringe 6mL FDA UDI

Identifiers

Primary DI / UDI-DI: H965701274620 FDA UDI
510(k) Number: K140194 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Angiographic syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 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

Category: Angiographic syringe

NAMIC is a sterile, manually-operated angiographic syringe designed for the administration of contrast media into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. This single-use device is intended for use with polycarbonate solution only and not with contrast medium injection systems. It features a piston design and has an expiration date.

Similar devices

Also classified as Angiographic syringe.

Merit Medical® — Merit Medical Systems, Inc. · Class II
Antmed — ShenZhen Antmed Co., Ltd · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Inject8™ — Merit Medical Systems, Inc. · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II

Cleared under the same submission

K140194 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 ea23c54d-439a-48f0-b19d-a8b9afb3b1bb 36 fields · synced Jul 22, 2026