Duns Number:961027315
Device Description: BLUE COMFORT BOUFFANT, 21 INCH
Catalog Number
3244
Brand Name
CARDINAL HEALTH
Version/Model Number
3244
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 2022
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYF
Product Code Name
CAP, SURGICAL
Public Device Record Key
2c15bbfb-8a86-4f1e-83da-67979781b230
Public Version Date
June 13, 2022
Public Version Number
5
DI Record Publish Date
May 24, 2018
Package DI Number
50885380019836
Quantity per Package
10
Contains DI Package
20885380019835
Package Discontinue Date
June 12, 2022
Package Status
Not 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 |