Duns Number:106712748
Catalog Number
-
Brand Name
Level 1
Version/Model Number
SWU-2007
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
K141686,K141686
Product Code
DWJ
Product Code Name
System, thermal regulating
Public Device Record Key
3b2e26f3-2c0c-4979-99e2-31760730a7c4
Public Version Date
August 17, 2018
Public Version Number
4
DI Record Publish Date
October 11, 2016
Package DI Number
30610586043363
Quantity per Package
10
Contains DI Package
10610586043369
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |