Duns Number:054326178
Device Description: Q-Care, Q4, Oral Cleansing & Suctioning System
Catalog Number
6414
Brand Name
Q-Care
Version/Model Number
6414
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 21, 2018
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
2e5a658f-7283-4535-9a2d-67bcdd7cda8a
Public Version Date
July 26, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
50618029841389
Quantity per Package
20
Contains DI Package
00618029841384
Package Discontinue Date
March 21, 2018
Package Status
Not 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 |