OASIS

GUDID 20650862114014

DRAIN, DRY DUAL TOTAL REC W/AC

ATRIUM MEDICAL CORPORATION

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