FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966660065
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
882VR-200-00-A
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
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
06970966660065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966660065069709666600656970966660065

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
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970966665220GENTEC®34U-OXY2023-08-01
06970966665886GENTEC®O-W200-F70-GS2023-08-01
06970966665893GENTEC®O-W200-F70-BS2023-08-01
06970966665909GENTEC®O-G200-F70-DS2023-08-01
06970966665916GENTEC®O-W200-F70-DS2023-08-01
06970966663936GENTEC®O-W200-F70 Series2023-07-05
06970966663721GENTEC®34I-OXY Series2023-06-21
06970966663776GENTEC®35I-OXY Series2023-06-21
06970966663820GENTEC®34U-OXY Series2023-06-21
06970966663875GENTEC®35U-OXY Series2023-06-21
06970966663929GENTEC®FM197A -70L-HS Series2023-06-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344148332MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
10197344148707MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
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08435510655150TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679033TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679064TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679071TITANIUM VAC REGHERSILL SLKDP2026-08-25
08435510679088TITANIUM VAC REGHERSILL SLKDP2026-08-25
10197344144181MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-08-07
10197344144693MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144709MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144716MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144747MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144785MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144822MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344146178MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344146215MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344146222MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24