Duns Number:544922461
Device Description: Disposable rectal temperature probe
Catalog Number
-
Brand Name
Launch
Version/Model Number
TAE03-16S
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181967
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
2bab3621-90ca-4db6-841f-32be01cac4bf
Public Version Date
September 10, 2019
Public Version Number
1
DI Record Publish Date
September 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 62 |