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Namic

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
NAMIC FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
INFLATION DEVICE W/GATEWAY Y ADAPT FDA UDI
Model / Reference
H965914041 FDA UDI
Description
INFLATION DEVICE W/GATEWAY Y ADAPT FDA UDI

Identifiers

Catalog Number
H965914041 FDA UDI
Primary DI / UDI-DI
10193489078077 FDA UDI
FDA Product Code
OEQ FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Pressure — 3040 KiloPascal FDA UDI

Category: Catheter/overtube balloon inflator, single-use

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

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI f5f9f975-3953-43c1-a8a0-9b2d326f1579 36 fields · synced Jun 1, 2026