DEVICE: NA (00851920007194)

Device Identifier (DI) Information

NA
ECG Intermediate Cable
In Commercial Distribution
01-02-0920
ZOE MEDICAL INCORPORATED
00851920007194
GS1

1
848429929 *Terms of Use
ECG Intermediate Cable, 3-lead, 2 meter, AAMI
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Device Characteristics

MR Unsafe
No
Yes
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrical-only medical device connection cable, reusable A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
MWI Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150620 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9c0913e4-d995-4521-a851-247f8a9d4088
July 06, 2018
3
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
978-887-4013
customersupport@zoemedical.com
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