Duns Number:108999095
Device Description: ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30s, Canada
Catalog Number
413BCN
Brand Name
Adtemp™
Version/Model Number
413BCN
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
ba74e18c-7b53-40a4-bcbe-4d96242e5772
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 01, 2017
Package DI Number
00634782595333
Quantity per Package
12
Contains DI Package
00634782895334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |