Duns Number:604483321
Device Description: 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04905 WO X 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04905 WO XL Shoulder Polar Pad
Catalog Number
10912
Brand Name
BREG
Version/Model Number
PC GLACIER W/ SHLDR XL WO
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
-
Product Code
ILO
Product Code Name
Pack, Hot Or Cold, Water Circulating
Public Device Record Key
d86b1a3a-284e-4be3-a57a-c8d770f9b79e
Public Version Date
March 29, 2018
Public Version Number
2
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 |