Duns Number:054326178
Device Description: Q-Care, Petite Oral Cleansing & Suctioning System
Catalog Number
6764
Brand Name
Q-Care
Version/Model Number
6764
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
7d8a4d82-f130-4cf0-9295-f0b915a36384
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
August 10, 2018
Package DI Number
50618029831106
Quantity per Package
20
Contains DI Package
00618029831101
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 |