Duns Number:073814568
Device Description: Blue Diamond® Gel Pad for Andrews® Frame . This Viscoelastic polymer gel pad protects a pa Blue Diamond® Gel Pad for Andrews® Frame . This Viscoelastic polymer gel pad protects a patients illiac crest against pressure and shear exerted from Andrew Frame. Also designed to be knelt on and protect pressure injuries on the knees
Catalog Number
BD2590
Brand Name
Blue Diamond
Version/Model Number
BD2590
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
a2f21c59-5949-4410-a434-5b0b3f2127e8
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 |