Duns Number:080456871
Device Description: Infant Skin Temperature Probe, Single Patient Use
Catalog Number
2074817-001
Brand Name
Airlife
Version/Model Number
2074817-001
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"
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
FMZ
Product Code Name
INCUBATOR, NEONATAL
Public Device Record Key
60c90f56-5722-4572-81ad-d27b0c9339b6
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 26, 2021
Package DI Number
70190752179617
Quantity per Package
50
Contains DI Package
20190752179612
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |