Duns Number:961027315
Device Description: BAG BREATHING 2L DIPPED Not Made with Natural Rubber Latex
Catalog Number
BBD2000LF
Brand Name
CARDINAL HEALTH
Version/Model Number
BBD2000LF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 20, 2023
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
Yes
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
0eb9b56c-558b-4838-b4be-4ca2f6b11eef
Public Version Date
August 16, 2019
Public Version Number
3
DI Record Publish Date
May 20, 2019
Package DI Number
50885380100152
Quantity per Package
30
Contains DI Package
10885380100154
Package Discontinue Date
August 20, 2023
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |