Namic

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: NAMIC FDA UDI
Generic Name: Stopcock FDA UDI
Device Name: NAMIC 10" Low Pressure Contrast Injection Line, Female to Male Luer Lock FDA UDI
Model / Reference: 81021102 FDA UDI
Description: NAMIC 10" Low Pressure Contrast Injection Line, Female to Male Luer Lock FDA UDI

Identifiers

Primary DI / UDI-DI: H965810211020 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Stopcock 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 10 Inch FDA UDI
Pressure — 500 Pound per Square Inch FDA UDI

Category: Stopcock

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

Similar devices

Also classified as Stopcock.

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NAMIC — MEDLINE INDUSTRIES, INC. · Class II
Demax — Beijing Demax Medical Technology Co., Ltd · Class II
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
Marquis® Stopcock — Merit Medical Systems, Inc. · Class II
Medex — ICU MEDICAL, INC. · Class II

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 95e3fa8c-4777-4b0d-a82e-d6a740a4db79 35 fields · synced May 31, 2026