Duns Number:193277717
Device Description: The holster device provides safe and convenient storage of the Yankauer Suction Tip betwee The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail.
Catalog Number
-
Brand Name
SuctionShield
Version/Model Number
PSC5300
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"
-
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
c3fd5755-6aa6-489a-aa0f-707a4c140f0a
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
August 08, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |