Duns Number:108999095
Device Description: ADTMEP II, Dual Scale, Rectal,Dig Thermometer, 30s, Disp pkg
Catalog Number
413RQ
Brand Name
Adtemp™
Version/Model Number
413RQ
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
K940686,K940686,K940686
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
cc5c4ca5-2b82-4cf4-abad-dec3d9f30364
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
00634782584375
Quantity per Package
12
Contains DI Package
00634782884376
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 |