Duns Number:368457563
Device Description: Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
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
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
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
d5e9f0fc-5f04-4f77-a30a-20965b45c8b2
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
Package DI Number
50190752106121
Quantity per Package
10
Contains DI Package
10190752106123
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |