FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966666081
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
882VR-200-DS-C
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
2023-10-30
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
06970966666081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966666081069709666660816970966666081

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
06970966665688GENTEC®193M Series2026-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344148462MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148479MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148486MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148493MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148509MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148516MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148523MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148530MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148547MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148554MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148561MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148578MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-30
10197344148608MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-29
10197344148615MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-29
10197344148622MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-29
10197344148639MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-29
10197344148646MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-29
10197344148653MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-10-29
10197344148592MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-30
10197344148332MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
10197344148707MEDLINEMEDLINE INDUSTRIES, INC.KDP2026-09-04
08435510650872TITANIUM VAC REGHERSILL SLKDP2026-08-25
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