Duns Number:068331990
Device Description: Rexall 9 Second Flexible Tip Digital Thermometer
Catalog Number
77-359
Brand Name
Rexall
Version/Model Number
77-359
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
K041516,K041516,K041516
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
2ba43ef1-1503-4e64-9f8c-5f6d4551c371
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10845717773598
Quantity per Package
72
Contains DI Package
30845717773592
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| U | Unclassified | 1 |