Duns Number:054326178
Device Description: Q-Care Covered Yankauer, Suction Handle, and Y- Connector
Catalog Number
6630
Brand Name
Q-Care
Version/Model Number
6630
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
eab1cd7c-93c3-40ac-a3eb-01684ca5780c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50618029800904
Quantity per Package
60
Contains DI Package
00618029800909
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 |