Duns Number:186855925
Device Description: Temperature probe-pouch with two TMP-1304
Catalog Number
TMP-1308
Brand Name
ThermaSolutions
Version/Model Number
TMP-1308
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"
-
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
K101244,K101244
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
ef407d59-ceec-4091-bfaa-fe665098bc2b
Public Version Date
May 14, 2021
Public Version Number
1
DI Record Publish Date
May 06, 2021
Package DI Number
10851450007128
Quantity per Package
10
Contains DI Package
00851450007121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |