DEVICE: Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor (00817980021396)

Device Identifier (DI) Information

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor
Model EZ
In Commercial Distribution
A13-0040
VASOMEDICAL, INC.
00817980021396
GS1

1
197210248 *Terms of Use
EZ™ Software CD & Data Cable for ECG Monitor
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41651 Electrocardiographic long-term ambulatory recording analyser application software
A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DSH RECORDER, MAGNETIC TAPE, MEDICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K073152 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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

d42d16d5-6333-4978-a041-d6246f9b5507
July 06, 2018
3
November 29, 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

[?]
+1(516)508-5818
eohara@vasomedical.com
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