Duns Number:007941230
Device Description: Thermometer Digital Oral Rectal Dual-Scale Neutral Cap 35-90 Second Read Time Not Made Wit Thermometer Digital Oral Rectal Dual-Scale Neutral Cap 35-90 Second Read Time Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
916820A
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)
-
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
d10fdb2e-19fe-4fc8-a33f-2e65d4e7e3d3
Public Version Date
June 22, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632106055
Quantity per Package
25
Contains DI Package
10885632106057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |