Duns Number:084042331
Device Description: Wrap the belt around your belly while making sure the pad is centered and placed under you Wrap the belt around your belly while making sure the pad is centered and placed under your abdomen for comfort and support.Hand wash in cold water with mild detergentAir dry
Catalog Number
BB001
Brand Name
ManaMed
Version/Model Number
Belly Band
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISR
Product Code Name
Band Or Belt, Pelvic Support
Public Device Record Key
896d4688-5d39-479e-b110-32264f8a8d19
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 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 | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |