Duns Number:368457563
Device Description: Infant Skin Temperature Probe, Single Patient Use
Catalog Number
6600-0208-700
Brand Name
Airlife
Version/Model Number
6600-0208-700
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
FMT
Product Code Name
WARMER, INFANT RADIANT
Public Device Record Key
f9453f22-ddd9-4cb3-8e61-fd42de062545
Public Version Date
September 06, 2021
Public Version Number
2
DI Record Publish Date
February 26, 2021
Package DI Number
50190752181203
Quantity per Package
10
Contains DI Package
10190752181205
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |