MINIMAX®

GUDID 20613994965138

OXYGENATOR CB3381 BIOACT MINIMAX S 4PKL

MEDTRONIC, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 20613994965138
• NIH Device Record Key: 8d4e2895-60e6-485a-9c90-709d2d236dc5
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MINIMAX®
• Version Model Number: CB3381
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994965134 [Primary]
GS1	20613994965138 [Package]; Contains: 00613994965134; Package: PK [4 Units]; Discontinued: 2018-10-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933586

FDA Product Code

• DTZ: OXYGENATOR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2015-06-09

On-Brand Devices [MINIMAX®]

• 20613994269786: RSVR 1316 MINIMAX INF STD ALN HRDSHL 4PK
• 20613994965138: OXYGENATOR CB3381 BIOACT MINIMAX S 4PKL