Duns Number:879782365
Device Description: Suction Easy Emergency Manual Suction Unit for emergency suction of the oral airway to cle Suction Easy Emergency Manual Suction Unit for emergency suction of the oral airway to clear fluids and airway obstructions. Compact, portable and completely disposable. No batteries, replacement parts of electricity required. Case of 40 units.
Catalog Number
-
Brand Name
Suction Easy
Version/Model Number
EMI610 CS
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
9f667b9b-ac7f-40e4-8dab-7e71233f319b
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 |