Eight Medical 8510

GUDID 00817278012587

Myocardial temperature probe, 15mm needle, 8' length, 1/8" Plug

Alliant Enterprises, LLC

General-purpose patient temperature probe, single-use

• Primary Device ID: 00817278012587
• NIH Device Record Key: e1d141e9-f8e0-4f73-8846-79d6245b26e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eight Medical
• Version Model Number: 8510
• Catalog Number: 8510
• Company DUNS: 121170653
• Company Name: Alliant Enterprises, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817278012570 [Primary]
GS1	00817278012587 [Package]; Contains: 00817278012570; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020365

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

Sterilization

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

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

[00817278012587]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-05
• Device Publish Date: 2018-02-20

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