Duns Number:121788819
Device Description: THERMOFLECT BLANKET, M, 50EA TS THERMOFLECT BLANKET, 48" X THERMOFLECT BLANKET, M, 50EA TS THERMOFLECT BLANKET, 48" X 48", SILVER, 5/BG, 10 BG/CS NW
Catalog Number
-
Brand Name
Thermoflect
Version/Model Number
5100-400
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"
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
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
1c745cd1-cd64-4b78-9aac-da1564a10cbc
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
Package DI Number
40612899510409
Quantity per Package
5
Contains DI Package
30612899510402
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |