Duns Number:783518983
Device Description: Features:~ Flexible tip for convenient use~ Accurate to ±0.1 °C / ±0.2 °F~ Waterproof~ Lar Features:~ Flexible tip for convenient use~ Accurate to ±0.1 °C / ±0.2 °F~ Waterproof~ Large easy-to-read LCD~ Last memory recall~ Fever alarm~ Low battery indicator~ Automatic shut-off~ For oral, rectal, or axillary use
Catalog Number
1546
Brand Name
Oral Temp Digital Thermometer
Version/Model Number
MT4035
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
91926a7a-015f-4051-82a3-ffed464db3a8
Public Version Date
June 14, 2018
Public Version Number
3
DI Record Publish Date
May 18, 2016
Package DI Number
10891237001543
Quantity per Package
12
Contains DI Package
00891237001546
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |