Duns Number:367919120
Device Description: Infant Skin Temperature Probe, Single Patient Use, (Lullaby™, Care Plus™)
Catalog Number
6600-0196-700
Brand Name
AirLife
Version/Model Number
6600-0196-700
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
b8289585-e414-4c61-b03a-e4327af2c202
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 17, 2016
Package DI Number
50885403252905
Quantity per Package
5
Contains DI Package
20885403252904
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |