SEADUC

Basic Information

• Brand Name: SEADUC
• Primary DI: 00860007555336
• Version / Model: EMI700
• Company Name: Em Innovations Inc
• Labeler DUNS: 879782365
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 1
• Public Version Date: 2022-10-31
• Public Version Status: New
• Public Device Record Key: bf1deec0-0c10-4ffa-b463-8aa5a83c299b

Device Description

The first and only completely hand held manual suction device with the capability to perform the SALAD technique. Affordable, effective and simple to use, SEADUC™ provides instant readiness for resuscitation.

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	00860007555336	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K882017	000