Duns Number:084042331
Device Description: Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibr Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure
Catalog Number
MFLOW51
Brand Name
ManaFlow51
Version/Model Number
MFLOW51
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200353
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
3830e371-0ec7-49c2-95c1-734361f5c04b
Public Version Date
November 10, 2020
Public Version Number
1
DI Record Publish Date
November 02, 2020
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 |