Duns Number:054326178
Device Description: Q-Care, Q4, Oral Cleansing & Suctioning System
Catalog Number
6414-NM
Brand Name
Q-Care
Version/Model Number
6414-NM
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
6bec6507-b3a8-4fa8-8c6d-1275e03220a9
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
September 14, 2017
Package DI Number
50618029831038
Quantity per Package
20
Contains DI Package
00618029831033
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 |