Duns Number:308667539
Device Description: Gas mixture cylinder 1 litre 5% CO2, 20.9% O2, balance: N2
Catalog Number
962-106
Brand Name
Gas mixture cylinder
Version/Model Number
962-106
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 28, 2016
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BXK
Product Code Name
GAS, CALIBRATION (SPECIFIED CONCENTRATION)
Public Device Record Key
49361fa7-7937-4bae-a3d6-721c55658b52
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 66 |