Duns Number:025460908
Device Description: STOCKING,STD, ANTI-EM,T-L,MD REG,LF
Catalog Number
PRM160844
Brand Name
Caring
Version/Model Number
PRM160844
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"
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
-
Product Code
DWL
Product Code Name
Stocking, medical support (to prevent pooling of blood in legs)
Public Device Record Key
28edc7b1-f85f-4b03-bee1-d69332a4c101
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
30080196297829
Quantity per Package
6
Contains DI Package
10080196297825
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |