Duns Number:001292192
Device Description: CAP DISINFECTION STRIP US
Catalog Number
306597
Brand Name
BD PureHub
Version/Model Number
306597
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
LKB
Product Code Name
Pad, alcohol, device disinfectant
Public Device Record Key
e3f9c35b-581e-4547-b2d4-81c8e7093e4f
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
May 08, 2020
Package DI Number
50382903065979
Quantity per Package
15
Contains DI Package
30382903065975
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |