OASIS

GUDID 20650862114014

DRAIN, DRY DUAL TOTAL REC W/AC

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: 20650862114014
• NIH Device Record Key: 080f779d-84e0-47d9-b50b-0a27e366dcba
• Commercial Distribution Discontinuation: 2017-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OASIS
• Version Model Number: 3652-100
• 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	00650862114010 [Primary]
GS1	20650862114014 [Package]; Contains: 00650862114010; Package: [6 Units]; Discontinued: 2017-10-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043140

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 [OASIS]

• 20650862114014: DRAIN, DRY DUAL TOTAL REC W/AC
• 20650862113017: OASIS DRAIN, BRU, IN-LINE, ATS COMPATIBLE
• 20650862112010: OASIS DRAIN, DUAL, IN-LINE, ATS COMPATIBLE
• 20650862111020: DRAIN, DRY PEDIATRIC
• 20650862111013: OASIS DRAIN, PEDIATRIC INLINE & CLAMP
• 20650862110092: DRAIN, SINGLE, W/AC, TYVEK
• 20650862110054: DRAIN, DRY SINGLE - SFP
• 20650862110030: DRAIN, DRY SINGLE W/AC, ATS
• 20650862110016: OASIS DRAIN, SINGLE, INLINE & ATS COMPATIBLE