Duns Number:324869601
Device Description: Rebreathing Bag with open tube connection and cap
Catalog Number
-
Brand Name
n.a.
Version/Model Number
66-00-042
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
BTC
Product Code Name
Bag, Reservoir
Public Device Record Key
dbd07765-121e-4718-b55f-5ed91113f2da
Public Version Date
September 12, 2022
Public Version Number
2
DI Record Publish Date
August 31, 2020
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 | 334 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |