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Gentec®

FDA UDI

Class II (US FDA UDI)

by Gentec(shanghai)corporation

Identity

Trade Name
GENTEC® FDA UDI
Generic Name
Vacuum suction regulator/regulation set, thoracic FDA UDI
Device Name
882EV series suction regulator is a continuous subglottic suction regulator .It can be used for medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning etc. FDA UDI
Model / Reference
882EV-70-L FDA UDI
Description
882EV series suction regulator is a continuous subglottic suction regulator .It can be used for medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning etc. FDA UDI

Identifiers

Primary DI / UDI-DI
06970966662649 FDA UDI
FDA Product Code
KDP FDA UDI
GMDN Term
Vacuum suction regulator/regulation set, thoracic 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: Vacuum suction regulator/regulation set, thoracic

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

Similar devices

Also classified as Vacuum suction regulator/regulation set, thoracic.

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 548199e5-7373-4e53-bf85-6f2c74f48159 33 fields · synced May 30, 2026