BioTrend®

GUDID 00613994638656

INSTRUMENT 95198-004 BIOTREND UNIV 8LEU

MEDTRONIC, INC.

Extracorporeal blood gas/pH monitor

• Primary Device ID: 00613994638656
• NIH Device Record Key: a1a5e689-3efb-4f07-a296-90964d766fea
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BioTrend®
• Version Model Number: 95198-004
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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 -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994638656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093650

FDA Product Code

• DTY: SENSOR, BLOOD-GAS, IN-LINE, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-19

On-Brand Devices [BioTrend®]

• 00613994638656: INSTRUMENT 95198-004 BIOTREND UNIV 8LEU
• 00613994638649: INSTRUMENT 95198-004 BIOTREND UNIV 8LDOM
• 00643169200906: INSTRUMENT 95198-004 BIOTREND UNIV 8LDOM
• 00763000216238: INS 95198-004 BIOTREND UNIV 8LEU
• 00763000216221: INSTRUMENT 95198-004 BIOTREND UNIV 8LDOM
• 00763000216269: INS R95198-004 BIOTREND UNIV 8LDOM
• 00763000216276: INS E95198-004 BIOTREND UNIV 8LDOM
• 00763000167332: INS R95198-04 BIOTREND UNIV 8LDOM