421-0115

GUDID 00851920007286

Temperature Adapter Cable (Zoe to YSI-400 1/4 inch plug)

ZOE MEDICAL INCORPORATED

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00851920007286
• NIH Device Record Key: ac5cb42f-6167-4051-90f1-526b8502be05
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Temperature Cable
• Catalog Number: 421-0115
• Company DUNS: 848429929
• Company Name: ZOE MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 978-887-4013
• Email: customersupport@zoemedical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851920007286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130740

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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: 2017-02-18

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