AccessGUDID - DEVICE: ECG NEO ADAPTER CABLE MM, 2M (04049098002097)

GUDID

Device Identifier (DI) Information

Brand Name: ECG NEO ADAPTER CABLE MM, 2M
Version or Model: MS25951
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DRAEGER MEDICAL SYSTEMS, INC.

Primary DI Number: 04049098002097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788289952 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35041	Electrosurgical cable adaptor	A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070566	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eac3824b-8c57-4b38-a5a6-8e55184aa2a3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015