Duns Number:831375089
Device Description: 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets
Catalog Number
3856
Brand Name
PremierPro
Version/Model Number
3856
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
5e6484c7-9fda-45f4-87f3-2eb45e599df2
Public Version Date
July 05, 2021
Public Version Number
2
DI Record Publish Date
April 05, 2019
Package DI Number
10811220031982
Quantity per Package
10
Contains DI Package
00811220031985
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 |