GENTEC®

Primary DI
06970966665688
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
193M Series
Device description
193M Series, Medical Gas Pressure Regulators
Published
2026-10-16
Public version status
New
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
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970966665688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966665688069709666656886970966665688

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed medical gas cylinder regulatorA reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.

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
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
00848530109455Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2026-07-23
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00848530108168RegulatorsSunset Healthcare Solutions, Inc.CAN2026-02-02
00848530108120RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530108151RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530107765Repair PartsSunset Healthcare Solutions, Inc.CAN2025-11-24
00848530107413React Regulator ValveSunset Healthcare Solutions, Inc.CAN2025-09-17
00848530106034Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
00848530106041Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
08592346893429VarimedGCE, s.r.o.CAN2025-03-17
08592346893436VarimedGCE, s.r.o.CAN2025-03-17
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
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G298153187270040NAControl Devices, LLCCAN2024-08-08
G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
G298153187280010NAControl Devices, LLCCAN2024-08-08
G298153187280020NAControl Devices, LLCCAN2024-08-08
G298153187280030NAControl Devices, LLCCAN2024-08-08
G298153187280040NAControl Devices, LLCCAN2024-08-08
G2982108080NAControl Devices, LLCCAN2024-08-08
G2982108150NAControl Devices, LLCCAN2024-08-08
G2982108250NAControl Devices, LLCCAN2024-08-08