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Gentec®

FDA UDI

Class II (US FDA UDI)

by Gentec(shanghai)corporation

Identity

Trade Name
GENTEC® FDA UDI
Generic Name
Tracheal suction vacuum regulator FDA UDI
Device Name
881VR series suction regulator is a dual purpose suction regulator with continuous suctioning mode and intermittent suctioning mode. It can be used to medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning (continuous) or gastrointestinal suction (intermittent) FDA UDI
Model / Reference
881VR-300-CH-D FDA UDI
Description
881VR series suction regulator is a dual purpose suction regulator with continuous suctioning mode and intermittent suctioning mode. It can be used to medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning (continuous) or gastrointestinal suction (intermittent) FDA UDI

Identifiers

Primary DI / UDI-DI
06970966660317 FDA UDI
FDA Product Code
KDP FDA UDI
GMDN Term
Tracheal suction vacuum regulator 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: Tracheal suction vacuum regulator

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

Similar devices

Also classified as Tracheal suction vacuum regulator.

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 b28bd58b-8e6d-4b75-b00c-4d65df289d74 33 fields · synced May 31, 2026