Duns Number:314101143
Device Description: Tympanic Temperature Module for measuring spot-check temperature in the ear for neonates, Tympanic Temperature Module for measuring spot-check temperature in the ear for neonates, pediatric and adult patients. The result of this measurement can be automatically adjusted to correspond to a different body reference site: Ear, Oral, Core and Rectal. The Module is compatible with IntelliVue Patient Monitors MP5SC/MP5-MP90 and MX400-MX800 and Avalon Fetal Monitors. Please check software requirements for compatibility. Package includes measurement device, holder for mounting on the table, on the wall or on the roll stand and starter pack of 96 covers.
Catalog Number
866149
Brand Name
PHILIPS IntelliVue Tympanic Temperature Module
Version/Model Number
Tympanic Temperature Module
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2022
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
edfd6491-7781-4f71-9ee1-74a30fe02624
Public Version Date
March 08, 2022
Public Version Number
6
DI Record Publish Date
November 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |