Duns Number:879782365
Device Description: Suction Easy Manual Emergency Suction Unit is a disposable, manually operated suction unit Suction Easy Manual Emergency Suction Unit is a disposable, manually operated suction unit for clearing fluids from the oral airway. No batteries, no electricity or replacement parts are needed. Compact and durable.
Catalog Number
-
Brand Name
Suction Easy
Version/Model Number
EMI610
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K882017
Product Code
BSY
Product Code Name
Catheters, Suction, Tracheobronchial
Public Device Record Key
fc576910-9dbd-497b-8f9f-d7d9d0dd198f
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |