Duns Number:073814568
Device Description: Blue Diamond® Gel axillary roll cover has Velcro® to keep it in placer once wrapped around Blue Diamond® Gel axillary roll cover has Velcro® to keep it in placer once wrapped around a non -gel roll. This offers a layer of gel pressure management to be added to basic foam axillary rolls.
Catalog Number
BD2405
Brand Name
Blue Diamond
Version/Model Number
BD2405
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
51a86feb-4b9f-4499-878f-4e9bdf9947f6
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 264 |