Duns Number:070849038
Device Description: 24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit inclu 24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
Catalog Number
-
Brand Name
ReddyPort
Version/Model Number
RP-MKITQ4-1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFW
Product Code Name
Toothbrush, Manual
Public Device Record Key
c77594b1-23a6-4f15-8d4d-99b759c9f3e2
Public Version Date
June 09, 2022
Public Version Number
2
DI Record Publish Date
November 18, 2020
Package DI Number
10850001175217
Quantity per Package
10
Contains DI Package
00850001175210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |