OCEAN

GUDID 20650862103032

DRAIN, TOTAL RECOVERY -STERILE

ATRIUM MEDICAL CORPORATION

Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir Cardiotomy reservoir

• Primary Device ID: 20650862103032
• NIH Device Record Key: 093036fd-00c7-4eb2-985f-dc9874cf547f
• Commercial Distribution Discontinuation: 2017-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OCEAN
• Version Model Number: 2050-070
• Company DUNS: 051798999
• Company Name: ATRIUM MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650862103038 [Primary]
GS1	20650862103032 [Package]; Contains: 00650862103038; Package: [6 Units]; Discontinued: 2017-10-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043582

FDA Product Code

• CAC: Apparatus, Autotransfusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2015-09-24

On-Brand Devices [OCEAN]

• 20650862104039: DRAIN, DUAL TOTAL RECOVERY W/S
• 20650862104015: DRAIN, DUAL TOTAL REC W/AC,S
• 20650862103063: DRAIN, TOTAL RECOVERY W/S
• 20650862103032: DRAIN, TOTAL RECOVERY -STERILE
• 20650862103018: OCEAN DRAIN, BRU, W/STOP, IN-LINE
• 20650862102059: OCEAN DRAIN, DUAL, W/STOPCOCK
• 20650862102042: DRAIN, DUAL W/AC
• 20650862102011: OCEAN DRAIN, DUAL, IN-LINE, STOP
• 20650862101038: DRAIN, PEDIATRIC W/S, TYVEK
• 20650862101021: OCEAN DRAIN, PEDIATRIC, IN-LINE, STOP
• 20650862100345: DRAIN, SINGLE, PEDI CONNECTOR
• 20650862100321: DRAIN, SINGLE,W/AC, S, ATS, SFP
• 20650862100215: OCEAN DRAIN, SINGLE, IN-LINE CONNECTOR
• 20650862100192: DRAIN, SINGLE W/S, TYVEK
• 20650862100109: OCEAN DRAIN, SINGLE W/STOPCOCK
• 20650862100093: DRAIN, SINGLE W/AC
• 20650862100062: DRAIN, SINGLE - STERILE FLUID
• 20650862100048: DRAIN, SINGLE W/AC, S, ATS
• 20650862100017: OCEAN DRAIN, SINGLE, IN-LINE, STOP