FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966662007
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
882VR-300-PB/E-TH
Device description
882VR series suction regulator is a 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.
Published
2017-06-01
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

Product Codes#

Code, Name table
CodeName
KDPRegulator, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970966662007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966662007069709666620076970966662007

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970966669167GENTEC®FMD197A Series2024-11-16
06970966669068GENTEC®FM-PTO2024-08-05
06970966669037GENTEC®Y-VAC-CPLR-OH2024-07-26
06970966669044GENTEC®Y-VAC-CPLR-DH2024-07-26
06970966669051GENTEC®Y-OXY-CPLR-OH2024-07-26
06970966666753GENTEC®195M-950D2024-06-28
06970966666371GENTEC® GMX30E-AIR/O2-DS-P152024-03-25
06970966666357GENTEC®882VR-200-00-T2023-12-26
06970966666340GENTEC®882VR-200-DS-T-1.5L2023-12-20
06970966666111GENTEC®881VR-200-DS-T-2.5L/Sld2023-11-22
06970966660140GENTEC®FM197A-15L2023-11-08
06970966664506GENTEC®FM197A-3L2023-11-08
06970966664513GENTEC®FM197A-6L2023-11-08
06970966665954GENTEC®FM197A-8L-002023-11-06
06970966666081GENTEC®882VR-200-DS-C2023-10-30
06970966666098GENTEC®882VR-200 (-DS-T)2023-10-30
06970966660225GENTEC®FM197A-15L-OH2023-09-26
06970966666005GENTEC®195MG-100P-CGA5402023-09-26
06970966666012GENTEC®195MG-100P-CGA8702023-09-26
06970966666029GENTEC®195MG-100P-CGA3262023-09-26

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Primary DI, Brand, Company table
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08435510680039TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680046TITANIUM VAC REGHERSILL SLKDP2026-01-07
08435510680053TITANIUM VAC REGHERSILL SLKDP2026-01-07
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