FDA.reportPublic FDA data

MM15 DY AIR DS _ 9/16 G

Primary DI
08592346749443
Brand
MM15 DY AIR DS _ 9/16 G
Company
GCE, s.r.o.
Model
0730105US
Device description
Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
Published
2021-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592346749443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346749443085923467494438592346749443

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, Thorpe tubeA device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
819753190
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592346978812MediVital EMVE25 O2 3/4UNF CGA540 DS S0718500US2025-08-08
08592346893382VarimedVM O2 CGA540 _ _ 9/16 S0729113US2025-03-17
08592346893399Varimed+VM+ O2 CGA540 _ _ 9/16 S0729114US2025-03-17
08592346893405VarimedVM O2 CGA870 _ _ 9/16 S0729115US2025-03-17
08592346893412Varimed+VM+ O2 CGA870 _ _ 9/16 S0729116US2025-03-17
08592346893429VarimedVM AIR CGA346 _ _ 9/16 S0729117US2025-03-17
08592346893436VarimedVM N2O CGA326 _ _ 9/16 S0729118US2025-03-17
08592346918276VarimedVM O2 CGA540 _ PTBH 9/16 G0729120US2025-03-17
08592346944831Varimed+VM+ N2O PI DS _ _ S0729125US2025-03-17
08592346944848VarimedVM N2O CGA326 DS _ _ S0729126US2025-03-17
08592346946033Varimed+VM+ CO2 CGA320 DS _ _ S0729127US2025-03-17
08592346946040VarimedVM CO2 CGA320 DS _ _ S0729128US2025-03-17
08592346935426Varimed+VM+ CO2 PI DS _ _ S0729123US2024-10-23
08592346935440Varimed+VM+ N2O CGA326 DS _ _ S0729124US2024-10-23
08592346935464Varimed+VM+ AIR PI DS _ _ S0729121US2024-10-23
08592346935471Varimed+VM+ AIR CGA346 DS _ _ S0729122US2024-10-23
08592346898165MediVitopMT25 O2 3/4UNF CGA540R DS S0712601US2024-06-13
08592346893443MR AIR_PI_DS _ _ G0724109US2023-12-12
08592346893450VM AIR PI _ _ 9/16 G0729119US2023-12-12
08592346892583MS25 O2 PI DS _ 9/16 S0720121US2023-12-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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