Duns Number:005910997
Device Description: BK10000F Cribmates Healthcare Kit 6 Piece Set Includes, Nail Clipper, Nasal Aspirator, Med BK10000F Cribmates Healthcare Kit 6 Piece Set Includes, Nail Clipper, Nasal Aspirator, Medicine Dropper, Medicine Spoon, Flex Tip Thermometer, Travel Case.
Catalog Number
-
Brand Name
Cribmates
Version/Model Number
BK10000F
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 31, 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
7334c4be-9526-4cd1-be95-3620c7bbb486
Public Version Date
April 01, 2022
Public Version Number
1
DI Record Publish Date
March 24, 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 |