FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966666340
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
882VR-200-DS-T-1.5L
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
2023-12-20
Public version status
New
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
06970966666340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966666340069709666663406970966666340

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

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
06970966666111GENTEC®881VR-200-DS-T-2.5L/Sld2023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344144693MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144723MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144747MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144761MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144785MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344144792MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344144822MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344147274MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
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10197344147335MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24
10197344147342MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-24