01-02-0920

GUDID 00851920007194

ECG Intermediate Cable, 3-lead, 2 meter, AAMI

ZOE MEDICAL INCORPORATED

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00851920007194
• NIH Device Record Key: 9c0913e4-d995-4521-a851-247f8a9d4088
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ECG Intermediate Cable
• Catalog Number: 01-02-0920
• 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

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851920007194 [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: 2016-09-22

Devices Manufactured by ZOE MEDICAL INCORPORATED

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• 00851920007408 - 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
• 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.