Duns Number:070849038
Device Description: ReddyPort Moisturizer Pack for use with ReddyPort Elbow. Moisturizer Pack includes: 1x su ReddyPort Moisturizer Pack for use with ReddyPort Elbow. Moisturizer Pack includes: 1x suction swab, 1x mouth moisturizer, 1x applicator swab
Catalog Number
-
Brand Name
Moisturizer
Version/Model Number
RP-MPK-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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
0dae8480-c69f-4792-8dd6-2cf4c091e905
Public Version Date
November 26, 2020
Public Version Number
1
DI Record Publish Date
November 18, 2020
Package DI Number
10850001175200
Quantity per Package
50
Contains DI Package
00850001175203
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 |