Duns Number:604483321
Device Description: 1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer 1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer
Catalog Number
C00001
Brand Name
BREG
Version/Model Number
VPULSE W/O PADS
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
K122640
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
781d5c9c-0677-4ddc-a24e-016125db33f6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 129 |