Duns Number:073814568
Device Description: Blue Diamond® Flat Bottom Chest Roll. These viscoelastic polymer gel pads have a thin ther Blue Diamond® Flat Bottom Chest Roll. These viscoelastic polymer gel pads have a thin thermoformed skin and simulate human adipose tissue. They are a versatile roll used for axillary, shoulders, chest distensions, under knees, as well as bolster rolls to keep patients in place. A wide variety of shaped & sizes are available. This particular one is more dome shaped.
Catalog Number
BD2490
Brand Name
Blue Diamond
Version/Model Number
BD2490
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"
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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
5f01ce1a-6527-4e1f-baf9-4ff3971f0b44
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 |