FDA.report

FRU, Hose, Mixed Gas, Original

Primary DI
00813830021080
Brand
FRU, Hose, Mixed Gas, Original
Company
ACCUTRON, INC.
Model
24344-FRU
Catalog number
24344-FRU
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00813830021080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830021080008138300210808138300210800813830021080

GMDN Terms

TermDefinition
Nitrous oxide quick-connect coupling, maleA male connecting device used to connect to a medical gas pipeline system or other gas source allowing a user to rapidly connect and disconnect nitrous oxide (N2O) dependent devices to the N2O supply. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection. It is used to connect into an N2O terminal unit or female connector. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector.

Sterilization Methods

Method

Regulatory Flags

DUNS number
088302096
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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