Duns Number:029351079
Device Description: Temperature Probe
Catalog Number
861527
Brand Name
MEAS 4400 Series Temperature Probe
Version/Model Number
4491
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
9b85faee-33e2-4dec-8644-676e36fff696
Public Version Date
October 19, 2018
Public Version Number
3
DI Record Publish Date
July 01, 2016
Package DI Number
H29744912
Quantity per Package
10
Contains DI Package
H29744911
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |