Duns Number:080361159
Device Description: THERMOMETER, BANNER DIGITAL ORAL, 60 SECOND READ, RIGID TIP, WHITE W/ BLUE TOP AND BANNER THERMOMETER, BANNER DIGITAL ORAL, 60 SECOND READ, RIGID TIP, WHITE W/ BLUE TOP AND BANNER HEALTH LOGO IN BLUE PANTONE 281, PACKAGED IN PLASTIC CASE W/ INSTRUCTION SHEET, 30EA/BX, 12BX/CS (360EA/CS)
Catalog Number
-
Brand Name
BANNER HEALTH
Version/Model Number
BHTRA01
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f3121d37-5815-4070-b710-fcf034512822
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 09, 2022
Package DI Number
10840216109596
Quantity per Package
30
Contains DI Package
00840216109599
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |