Duns Number:005910997
Device Description: 6pc. Healthcare Kit Includes: Nail Clippers, Nasal Aspirator, Medicine Dropper, Digital Th 6pc. Healthcare Kit Includes: Nail Clippers, Nasal Aspirator, Medicine Dropper, Digital Thermometer, Medicine Spoon, and Travel Case.
Catalog Number
-
Brand Name
Playtex Baby
Version/Model Number
PL81000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 29, 2023
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
0074b0cd-da9d-443c-8bc0-56894fbd2958
Public Version Date
April 06, 2022
Public Version Number
1
DI Record Publish Date
March 29, 2022
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. | 9 |