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Gentec®

FDA UDI

Class II (US FDA UDI)

by Gentec(shanghai)corporation

Identity

Trade Name
GENTEC® FDA UDI
Generic Name
General-purpose surgical suction system, pneumatic FDA UDI
Device Name
880VS series medical suction kit （aka suction kit） is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction. FDA UDI
Model / Reference
880VS-760-CH/A-00 FDA UDI
Description
880VS series medical suction kit （aka suction kit） is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction. FDA UDI

Identifiers

Primary DI / UDI-DI
06970966662625 FDA UDI
FDA Product Code
KDP FDA UDI
GMDN Term
General-purpose surgical suction system, pneumatic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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: General-purpose surgical suction system, pneumatic

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

Similar devices

Also classified as General-purpose surgical suction system, pneumatic.

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 d7921cd2-6661-4360-90d9-63b73d40664d 33 fields · synced Jun 7, 2026