DEVICE: MediMax Tech (00817325023191)
Device Identifier (DI) Information
MediMax Tech
MXNSR15A
In Commercial Distribution
MEDIMAX TECH INC.
MXNSR15A
In Commercial Distribution
MEDIMAX TECH INC.
MXNSR15A ELECTRODE, PRE-WIRED, RADIO-TRANSLUCENT, 24 IN, 26X40MM SQUARE- SINGLE PACK OF 3
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
35035 | Electrocardiographic electrode, single-use |
A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRX | Electrode, Electrocardiograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020003 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ae643a81-c4c5-4d2e-ab20-2d49eab859b2
July 12, 2018
1
June 11, 2018
July 12, 2018
1
June 11, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20817325023195 | 10 | 10817325023198 | In Commercial Distribution | Master Case | |
10817325023198 | 10 | 00817325023191 | In Commercial Distribution | Inner Pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8556334629
support@medimaxtech.com
support@medimaxtech.com