FDA.reportPublic FDA data

MediFlow Ultra II

Primary DI
08592346749399
Brand
MediFlow Ultra II
Company
GCE, s.r.o.
Model
0728102US
Catalog number
MFU25PDSA9HBUCG
Device description
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
Published
2021-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
08592346749399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346749399085923467493998592346749399

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 mixtures) cylinder to lower 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
819753190
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592346748033MediFlowTec0726501USMFT 25 _ O2 DS _9/16 G2021-02-17
08592346749375MediFlowTec0726502USMFT 25 _ AIR DS _ 9/16 G2021-02-17
08592346849563MediMeter0730113USMM30 _O2 DS _ 9/16UNF S2022-10-03
08592346849570MediMeter0730114USMM60 _O2 DS _ 9/16UNF S2022-10-03
08592346820975MediConnect0731020USMCN AIR Y2 DSF DS S2022-07-21
08592346820982MediConnect0731021USMCN VAC W1 DSF DSF S2022-07-21
08592346820999MediConnect0731022USMCN VAC W1 DSF DS S2022-07-21
08592346821002MediConnect0731023USMCN VAC W2 DSF DSF S2022-07-21
08592346821019MediConnect0731024USMCN VAC W2 DSF DS S2022-07-21
08592346756434MediConnect0731007USMCN AIR Y2 DSF DSF G2022-07-20
08592346756441MediConnect0731005USMCN AIR Y1 DSF DSF G2022-07-20
08592346756793MediConnect0731004USMCN O2 G2 DSF DS G2022-07-20
08592346756809MediConnect0731006USMCN AIR Y1 DSF DS G2022-07-20
08592346756816MediConnect0731008USMCN AIR Y2 DSF DS G2022-07-20
08592346756823MediConnect0731009USMCN VAC W1 DSF DSF G2022-07-20
08592346756830MediConnect0731010USMCN VAC W1 DSF DS G2022-07-20
08592346756847MediConnect0731011USMCN VAC W2 DSF DSF G2022-07-20
08592346756854MediConnect0731012USMCN VAC W2 DSF DS G2022-07-20
08592346756878MediConnect0731002USMCN O2 G1 DSF DS G2022-07-20
08592346820906MediConnect0731013USMCN O2 G1 DSF DSF S2022-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
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
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G298153187220010NAControl Devices, LLCCAN2024-07-26
G298153187220020NAControl Devices, LLCCAN2024-07-26