Duns Number:100439103
Device Description: Flowtron bariatric sequential calf garment - fits up to 32 inch calf circumference
Catalog Number
-
Brand Name
DVT Sleeve
Version/Model Number
RM-TRP 60L
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
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
K031559,K031559
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
b6c8768a-a7bb-4d35-a1a0-b093e2caf360
Public Version Date
August 02, 2019
Public Version Number
5
DI Record Publish Date
February 23, 2017
Package DI Number
10816317023178
Quantity per Package
10
Contains DI Package
00816317023171
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 68 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |