Duns Number:355804758
Device Description: DVT Prevention Compression Garment - DVT 30 STERILE - CALF/THIGH
Catalog Number
-
Brand Name
Flowtron
Version/Model Number
DVT30S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 09, 2020
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
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
-
Product Code
JOW
Product Code Name
SLEEVE, LIMB, COMPRESSIBLE
Public Device Record Key
07eb1577-7f76-4c3d-b46b-5d332a7e9dcf
Public Version Date
September 05, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2016
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 | 420 |
2 | A medical device with a moderate to high risk that requires special controls. | 840 |