Duns Number:080887689
Device Description: GIRAFFE PANDA DISPOSABLE INFANT SKIN TEMPERATUR PROBE
Catalog Number
-
Brand Name
GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE
Version/Model Number
NA
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"
-
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
K201628,K123309,K152809,K152814
Product Code
FMT
Product Code Name
WARMER, INFANT RADIANT
Public Device Record Key
f357c676-97a1-448a-bc21-c0a045d77595
Public Version Date
November 18, 2021
Public Version Number
1
DI Record Publish Date
November 10, 2021
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 1 |