Duns Number:080216804
Device Description: RespVac Yankauer Suction Handle Bulb Tip Non-Vented Sterile
Catalog Number
RTG-03020
Brand Name
RespVac™
Version/Model Number
RTG-03020
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
111701a8-8c41-4f4b-901c-1ea5edfa407d
Public Version Date
May 11, 2020
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
10850108006551
Quantity per Package
50
Contains DI Package
00850108006554
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |