Duns Number:795104769
Device Description: Large Kit: Contains (1) Adult Cap and (1) Large Blanket
Catalog Number
7022-0001
Brand Name
ThermalX
Version/Model Number
961
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
ff9d6ba0-0675-490f-978a-6e1b091ce81a
Public Version Date
August 16, 2019
Public Version Number
1
DI Record Publish Date
August 08, 2019
Package DI Number
20615089702208
Quantity per Package
24
Contains DI Package
10615089702201
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 |