Duns Number:529903321
Catalog Number
-
Brand Name
Motorola
Version/Model Number
TE-94
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
K140681,K140681,K140681
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
952f6479-f775-416e-88ea-6d12c75b10da
Public Version Date
November 10, 2020
Public Version Number
1
DI Record Publish Date
November 02, 2020
Package DI Number
16947468500097
Quantity per Package
1
Contains DI Package
06947468500090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
1pcs/box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |