Duns Number:658863238
Device Description: Relief Aire LAL Cover 54'' × 84'' QLT H&R-1P
Catalog Number
-
Brand Name
NA
Version/Model Number
S2001-A770
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
IOQ
Product Code Name
Bed, Flotation Therapy, Powered
Public Device Record Key
f1d8d49f-b96e-424a-b4aa-977e0949befc
Public Version Date
July 27, 2021
Public Version Number
1
DI Record Publish Date
July 19, 2021
Package DI Number
04713616091749
Quantity per Package
10
Contains DI Package
04713616091725
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |