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
1236d6b5-ddde-4624-b68a-154e669f02d3
Public Version Date
January 06, 2020
Public Version Number
1
DI Record Publish Date
December 27, 2019
Package DI Number
26947468554714
Quantity per Package
12
Contains DI Package
16947468554717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
12pcs/box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |