FDA.report

GENTEC®

Primary DI
06970966660423
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
881VR-160-CH-A
Device 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)
Published
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KDPRegulator, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06970966660423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06970966660423069709666604236970966660423

GMDN Terms

TermDefinition
Tracheal suction vacuum regulatorA device designed to connect to the vacuum terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure (vacuum) provided by the system and applied in the evacuation of fluids, mucus or solids from the trachea. The device is connected either directly or via dedicated vacuum tubing to the wall outlet and helps provide continuous or intermittent suction at variable levels. It is typically constructed of metal and plastic and includes a manometer for monitoring suction/vacuum pressure. It may include a disposable antibacterial filter, a collection bottle and a mechanical anti-overflow mechanism to help protect the device and the vacuum pipeline system.

Sterilization Methods

Method

Regulatory Flags

DUNS number
545287658
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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