FDA.reportPublic FDA data

Ohio

Primary DI
00628101620387
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
GR-CS-PA-01001
Catalog number
GR-CS-PA-01001
Device description
GR 50 PSI PRESET FM 15LPM OXYGEN CGA 477
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00628101620387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101620387006281016203876281016203870628101620387

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.

Contacts#

Phone, Email table
PhoneEmail
+1(866)549-6446customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101620837OhioGR-CS-AS-01001GR-CS-AS-010012026-05-18
00628101620851OhioGR-MU-00101GR-MU-001012026-05-18
00628101632618OhioAM-TH300440AM-TH3004402026-05-18
00628101632625OhioGR-F4OGR-F4O2026-05-18
00628101632496Ohio HS-13IV-DFXXC4 HS-13IV-DFXXC42026-05-13
00628101632502OhioHS-13U2-DFXXC4HS-13U2-DFXXC42026-05-13
00628101632557Ohio HS-01UW-CFCMC4 HS-01UW-CFCMC42026-05-13
00628101632472OhioHS-15UV-F2CMC4HS-15UV-F2CMC42026-05-06
00628101632519OhioHS-20UO-DEOEC4HS-20UO-DEOEC42026-05-06
00628101632526Ohio HS-20UA-DAOEC4 HS-20UA-DAOEC42026-05-06
00628101632540OhioHS-25UI-DFXXC4HS-25UI-DFXXC42026-05-06
00628101632434Ohio HS-30U2-CFDFC4 HS-30U2-CFDFC42026-05-05
00628101632441Ohio HS-30UW-CFDFC5 HS-30UW-CFDFC52026-05-05
00628101632533OhioHS-CS-RM-02002HS-CS-RM-020022026-05-05
00628101632489Ohio HS-25UC-DFF4C4 HS-25UC-DFF4C42026-04-17
00628101608187OhioFI-T01UO-DN-EFI-T01UO-DN-E2026-04-15
00628101608194OhioFI-T01UO-ON-EFI-T01UO-ON-E2026-04-15
00628101608200OhioFI-T03UO-CN-BFI-T03UO-CN-B2026-04-15
00628101608217OhioFI-T03UO-CN-EFI-T03UO-CN-E2026-04-15
00628101608224OhioFI-T03UO-DN-BFI-T03UO-DN-B2026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00819601025837EscalonAirgas Therapeutics, LLCCAN2025-11-21
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
G298153187270020NAControl Devices, LLCCAN2024-08-08
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
G2982212200NAControl Devices, LLCCAN2024-08-08
G2982216200NAControl Devices, LLCCAN2024-08-08
G2982217200NAControl Devices, LLCCAN2024-08-08
G298153187280050NAControl Devices, LLCCAN2024-07-30
G298153187280080NAControl Devices, LLCCAN2024-07-30
G298202230NAControl Devices, LLCCAN2024-07-30
G298153187220010NAControl Devices, LLCCAN2024-07-26
G298153187220020NAControl Devices, LLCCAN2024-07-26
G298153187220040NAControl Devices, LLCCAN2024-07-26