DEVICE: Single Pat Use ECG 3-Lead IEC1 (04048675251101)
Device Identifier (DI) Information
Single Pat Use ECG 3-Lead IEC1
MP00875
In Commercial Distribution
Drägerwerk AG & Co. KGaA
MP00875
In Commercial Distribution
Drägerwerk AG & Co. KGaA
No description.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
61821 | Electrocardiographic lead set, single-use |
A collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IKD | Cable, Electrode |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
81fbc9da-5906-44ca-ab2e-55aa705771ec
August 16, 2018
3
October 24, 2015
August 16, 2018
3
October 24, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04048675421771
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+494518820
info@draeger.com
info@draeger.com