OCEAN

GUDID 20650862103032

DRAIN, TOTAL RECOVERY -STERILE

ATRIUM MEDICAL CORPORATION

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