Duns Number:527173399
Catalog Number
-
Brand Name
XinjingProWellness™
Version/Model Number
1010-C
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
c8e26b0a-af9d-4034-b1b2-7a0b1ad30516
Public Version Date
January 03, 2022
Public Version Number
1
DI Record Publish Date
December 24, 2021
Package DI Number
16973881680023
Quantity per Package
50
Contains DI Package
06973881680026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Boxes
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |