Duns Number:529903321
Catalog Number
-
Brand Name
Bytech
Version/Model Number
EQ-HW-TH-150-DI
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
94dfaded-6ac3-4f97-a7a6-27218598b36b
Public Version Date
March 27, 2020
Public Version Number
1
DI Record Publish Date
March 19, 2020
Package DI Number
16947468554786
Quantity per Package
1
Contains DI Package
06947468554789
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 |