FDA.report

MCN O2 G2 DSF DSF G

Primary DI
08592346756885
Brand
MCN O2 G2 DSF DSF G
Company
GCE, s.r.o.
Model
0731003US
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
2021-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08592346756885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08592346756885085923467568858592346756885

GMDN Terms

TermDefinition
General-gas low pressure tubing, reusableA non-sterile length of flexible tube intended to conduct compressed medical gas typically from a cylinder to a respiratory medical device outside of a static clinical environment (e.g., emergency CPAP device); it is not dedicated for use with a specific gas. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 15 bar), having been reduced by a regulator from a high pressure. The tubing is available in various lengths, including standard coil lengths; it is not colour-coded. This is a reusable device.

Sterilization Methods

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

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