FDA.reportPublic FDA data

MediConnect

Primary DI
08592346756830
Brand
MediConnect
Company
GCE, s.r.o.
Model
0731010US
Catalog number
MCN VAC W1 DSF DS G
Device description
Low-pressure hoses are intended for the transfer of medical gases or vacuum, and/or the connection of two medical products (e.g. a pressure regulator with an emergency ventilator).
Published
2022-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592346756830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346756830085923467568308592346756830

GMDN Terms#

Term, Definition table
TermDefinition
Mixed-respiratory-gas low pressure hoseA length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct a specific compressed medical gas mixture (e.g., helium/oxygen, nitrous oxide/oxygen mixture) from a specific terminal unit or cylinder to an appropriate respiratory/ventilatory medical device. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.

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
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
08592346820913MediConnect0731014USMCN O2 G1 DSF DS S2022-07-20

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Primary DI, Brand, Company table
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