Duns Number:604483321
Device Description: 1 Ice Water Container, 1 12 VDC output and 240 VAC, 60Hz input transformer and 1 C00016 Co 1 Ice Water Container, 1 12 VDC output and 240 VAC, 60Hz input transformer and 1 C00016 Cold Comp Universal Pad
Catalog Number
100580-000
Brand Name
BREG
Version/Model Number
100580-000
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
K183702
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
b1c417a4-aabf-4210-ab1e-890f8dc05fe6
Public Version Date
April 09, 2020
Public Version Number
1
DI Record Publish Date
April 01, 2020
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 |