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
10197344142460MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142477MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142484MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142491MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142507MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142514MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344142521MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143306MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143313MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143320MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143337MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143344MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143351MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143368MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143726MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143733MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143740MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143764MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344143771MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144433MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144440MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144457MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144464MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144471MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144488MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144495MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344144549MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146284MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146291MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09
10197344146307MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-06-09