Suction Easy

Basic Information

• Brand Name: Suction Easy
• Primary DI: 10860007555326
• Version / Model: EMI610 CS
• Company Name: Em Innovations Inc
• Labeler DUNS: 879782365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-20
• Public Version: 1
• Public Version Date: 2022-04-28
• Public Version Status: New
• Public Device Record Key: 9f667b9b-ac7f-40e4-8dab-7e71233f319b

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63644	Emergency airway clearance suction pump, manual	A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. It may include collection containers, microbial filter, valve, or tubing; it does not include patient contact devices (e.g., tips, catheters). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860007555326	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K882017	000