Duns Number:961027315
Device Description: BREATHING BAG, 3L, LATEX FREE
Catalog Number
BB3000LF
Brand Name
CARDINAL HEALTH
Version/Model Number
BB3000LF
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
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
9251f658-ca8a-44b4-93c6-3d614fd04895
Public Version Date
May 28, 2019
Public Version Number
1
DI Record Publish Date
May 20, 2019
Package DI Number
50885380063815
Quantity per Package
30
Contains DI Package
10885380063817
Package Discontinue Date
-
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 |