Namic

FDA UDI

Class I (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: NAMIC FDA UDI
Generic Name: Stopcock FDA UDI
Device Name: NAMIC 12" Pressure Monitoring Line, Male to Male Luer Lock FDA UDI
Model / Reference: 80642122 FDA UDI
Description: NAMIC 12" Pressure Monitoring Line, Male to Male Luer Lock FDA UDI

Identifiers

Primary DI / UDI-DI: H965806421220 FDA UDI
FDA Product Code: DRI FDA UDI
GMDN Term: Stopcock FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.2620 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

Yes

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 — 12 Inch FDA UDI

Category: Stopcock

Namic by Navilyst Medical, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Navilyst Medical, Inc.

Sources (1)

FDA UDI a6cceb2f-1d01-41d1-8bed-ee9878d406ec 35 fields · synced May 30, 2026