Duns Number:080935429
Device Description: 3000 Thermometer Probe,Oral/Axillary with 9? (2.7 m) Cord
Catalog Number
500027
Brand Name
Filac
Version/Model Number
500027
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2021
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)
Yes
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
5ad726f8-613f-48e6-84ec-a9fbfdef8f10
Public Version Date
October 11, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
30884521008131
Quantity per Package
100
Contains DI Package
20884521008134
Package Discontinue Date
February 18, 2021
Package Status
Not in Commercial Distribution
Package Type
PALLET
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |