Duns Number:030650113
Device Description: Flexible Yankauer Suction Tube, Regular Capacity with Port
Catalog Number
1284-03
Brand Name
Medovations®
Version/Model Number
1284-03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
73fa2104-d9cc-4bee-95e4-04b280f14bdf
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
September 07, 2018
Package DI Number
M7831284031
Quantity per Package
50
Contains DI Package
M7831284030
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |