Duns Number:083171244
Device Description: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyuretha BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.
Catalog Number
-
Brand Name
BioPatch™
Version/Model Number
3151
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003229,K003229,K003229
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
6135e3eb-fcb1-4311-802a-505f224de12b
Public Version Date
September 22, 2020
Public Version Number
6
DI Record Publish Date
June 20, 2016
Package DI Number
30705031004348
Quantity per Package
4
Contains DI Package
20705031004341
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |