Duns Number:831375089
Device Description: PremierPro Hot/Cold Therapy Blanket, Knee/Shoulder, Non-Sterile
Catalog Number
1238PP
Brand Name
PremierPro
Version/Model Number
1238PP
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
ILO
Product Code Name
Pack, Hot Or Cold, Water Circulating
Public Device Record Key
88e303de-18f5-4e0b-becb-4e78c2150fc6
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 2020
Package DI Number
10818566016109
Quantity per Package
10
Contains DI Package
00818566016102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |