Duns Number:108999095
Device Description: ADTEMP 418 Digital Thermometer, Flex-tip, Lrg Disp, 8 sec, BMWS-5 sheaths
Catalog Number
418N
Brand Name
Adtemp™
Version/Model Number
418N
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
K043110,K043110,K043110
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
595e8282-3e02-46ca-8a52-769cc89b80dc
Public Version Date
November 23, 2020
Public Version Number
4
DI Record Publish Date
November 24, 2017
Package DI Number
00634782588335
Quantity per Package
12
Contains DI Package
00634782888336
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 |