Duns Number:054326178
Device Description: Q-Care Rx, Oral cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Ora Q-Care Rx, Oral cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
Catalog Number
6982
Brand Name
Q-Care Rx
Version/Model Number
6982
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
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
ab057354-93fd-4168-a159-de11a562efc7
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
December 10, 2018
Package DI Number
50618029831144
Quantity per Package
10
Contains DI Package
00618029831149
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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |