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Gentec®

FDA UDI

Class I (US FDA UDI)

by Gentec(shanghai)corporation

Identity

Trade Name
GENTEC® FDA UDI
Generic Name
Medical air low pressure hose FDA UDI
Device Name
35I-AIR Series, Low pressure hose assemblies for use with medical gases, AIR FDA UDI
Model / Reference
35I-AIR Series FDA UDI
Description
35I-AIR Series, Low pressure hose assemblies for use with medical gases, AIR FDA UDI

Identifiers

Primary DI / UDI-DI
06970966663790 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
Medical air low pressure hose FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical air low pressure hose

Gentec® by Gentec(shanghai)corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical air low pressure hose.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gentec(shanghai)corporation

Sources (1)

  • FDA UDI ab5ef694-58ad-4bb0-aad1-81d2056d4a88 34 fields · synced Jun 1, 2026