Duns Number:006309355
Device Description: Zooby Pediatric Bibs, Assorted, Non-Permeable Pediatric Size (13.5 x 9 inches), Disposable
Catalog Number
295200
Brand Name
Zooby
Version/Model Number
295200
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
KHR
Product Code Name
ABSORBER, SALIVA, PAPER
Public Device Record Key
6aeac51e-4178-46a6-8131-ada549eab9ed
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302732952006
Quantity per Package
100
Contains DI Package
00302732952009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |