01-02-0925

GUDID 00851920007262

ECG 3-Lead Set, 1 meter, Mini-grabber, IEC.

ZOE MEDICAL INCORPORATED

Electrocardiographic lead set, reusable

• Primary Device ID: 00851920007262
• NIH Device Record Key: 5fb0dcc5-b4ca-40f1-9713-64104dd3aebf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ECG Lead, 1 meter
• Catalog Number: 01-02-0925
• 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	00851920007262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150620

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: 2017-01-31

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• 00851920007415 - 740 SELECT: 2021-07-22 The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, in
• 00851920007422 - 740 SELECT: 2021-07-22 The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, in
• 00851920007439 - NA: 2021-05-18 ECG Intermediate Cable, 3-lead, 2 meter, AAMI/IEC
• 00851920007392 - 740 SELECT: 2020-05-12 The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, in
• 00851920007385 - 740 SELECT: 2019-09-04 The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, in
• 00851920007163 - NA: 2019-07-22 Non-invasive Blood Pressure Hose, 3 meter. Female HP Connectors.