DEVICE: EV1000 (00690103193879)

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Device Record History
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Device Identifier (DI) Information
EV1000
EVNIDBAC
In Commercial Distribution
EVNIDBAC
Edwards Lifesciences LLC
00690103193879
GS1

1
134139174 *Terms of Use
EV1000 NI DATABOX ADAPTOR CABL
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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?
47487 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.
Active false
43267 Patient positioning sensor
A device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DSB PLETHYSMOGRAPH, IMPEDANCE
DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K140312 000
K160552 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.
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Clinically Relevant Size

[?]
Size Type Text
Length: 51 Inch
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Device Record Status
0c13fcdb-a89e-4ed6-961c-2b96c6d0e599
February 22, 2021
4
September 03, 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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
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