Duns Number:002144145
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
10150
Brand Name
BIOPATCH
Version/Model Number
10150
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
10119bb1-70ce-4538-8759-cdef4be9b5b8
Public Version Date
May 26, 2021
Public Version Number
13
DI Record Publish Date
July 18, 2016
Package DI Number
30705031001101
Quantity per Package
500
Contains DI Package
10705031001107
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |