Temporary Myocardial Heartwire

GUDID 00836559001850

Oscor Inc.

Transthoracic pacing lead

• Primary Device ID: 00836559001850
• NIH Device Record Key: 378c9321-9be0-4bf2-8416-6f6dbcf881eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temporary Myocardial Heartwire
• Version Model Number: TME 66 S
• Company DUNS: 101835833
• Company Name: Oscor 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559001850 [Primary]

FDA Product Code

• LDF: Electrode, Pacemaker, Temporary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-07
• Device Publish Date: 2015-10-16

On-Brand Devices [Temporary Myocardial Heartwire]

• 00885672101831: TME 228 TC-2.5
• 30836559004692: Temporary Myocardial Heartwire, Bipolar
• 30836559004616: Temporary Myocardial Heartwire, Bipolar
• 30836559004609: Temporary Myocardial Heartwire, Unipolar
• 30836559003992: Temporary Myocardial Heartwire, Bipolar
• 30836559001899: Temporary Myocardial Heartwire, Unipolar
• 30836559001813: Temporary Myocardial Heartwire, Bipolar
• 30836559001790: Temporary Myocardial Heartwire, Bipolar
• 30836559001776: Temporary Myocardial Heartwire, Unipolar
• 30836559001769: Temporary Myocardial Heartwire, Unipolar
• 30836559001752: Temporary Myocardial Heartwire, Unipolar
• 30836559001745: Temporary Myocardial Heartwire, Unipolar
• 20885672102115: Temporary Myocardial Heartwire, Quadripolar
• 20836559004701: Temporary Myocardial Heartwire, Bipolar
• 20836559004022: Temporary Myocardial Heartwire, Bipolar
• 00836559004646: TME 225 TC
• 00836559004639: TME 224 TC
• 00836559001959: TME 228 TC
• 00836559001942: TME 228 TS
• 00836559001928: TME 227 TS
• 00836559001874: TME 66 C
• 00836559001850: TME 66 S
• 00836559001829: TME 64 S-3
• 00836559001805: TME 65 S
• 00836559001782: TME 64 S
• 00836559001911: Temporary Myocardial Heartwire
• 00836559001904: Temporary Myocardial Heartwire