Duns Number:654591569
Device Description: BGEcare Anti-Embolism Stockings Thigh High Open Toe Medium, White(1 Pair)
Catalog Number
-
Brand Name
BGEcare Anti-Embolism Stockings
Version/Model Number
BGE20023TOM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 06, 2021
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)
-
Over the Counter (OTC)
Yes
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
16ab78c9-57c4-4b3c-b46b-92ee2fcdaeb7
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 05, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |