Duns Number:795104769
Device Description: Kit: Medium Blanket; Adult Cap; 2 legs
Catalog Number
7021-0001
Brand Name
ThermalX
Version/Model Number
951
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FME
Product Code Name
Gown, Examination
Public Device Record Key
dfe383a0-8af8-469f-8224-d60e3a0bebda
Public Version Date
October 14, 2019
Public Version Number
1
DI Record Publish Date
October 04, 2019
Package DI Number
20615089702109
Quantity per Package
20
Contains DI Package
10615089702102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |