Duns Number:051957769
Device Description: RELION 60 SEC DIG THERM W/BEEPER FAHRE IN BOX
Catalog Number
144-691-000
Brand Name
RELION
Version/Model Number
144-691-000
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f1e96cc0-5e50-4bcf-acc7-cdb5938dc774
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 17, 2016
Package DI Number
10681131060247
Quantity per Package
24
Contains DI Package
30681131060241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |