OCEAN

Basic Information

• Brand Name: OCEAN
• Primary DI: 00650862102017
• Version / Model: 2020-000
• Company Name: Atrium Medical Corporation
• Labeler DUNS: 051798999
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 7
• Public Version Date: 2024-01-16
• Public Version Status: Update
• Public Device Record Key: 3f0ab85b-294f-4df6-88c1-fa4215102f63
• Distribution End Date: 2022-10-01

Device Description

OCEAN DRAIN, DUAL, IN-LINE, STOP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	BOTTLE, COLLECTION, VACUUM	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63652	Thoracic suction collection container	A device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20650862102011	GS1		6	Not in Commercial Distribution	2022-10-01
Primary	00650862102017	GS1

Premarket Submissions

Submission Number	Supplement Number
K043582	000