AccessGUDID - DEVICE: MX40 Masimo Leadsets and Adapters (00884838091276)

GUDID

Device Identifier (DI) Information

Brand Name: MX40 Masimo Leadsets and Adapters
Version or Model: MX40 Adapter 6-Lead + Masimo SpO2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803204291
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838091276
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: MX40 Adapter 6-Lead + Masimo SpO2. For use with MX Telemetry systems. Supports IntelliVue connector style disposable and reusable ECG leadsets and DIN prewired electrodes on the MX Telemetry Systems. Supports Masimo SpO2 accessories defined for MX Telemetry systems. 6 lead ECG + Masimo SET SpO2. Quantity 1, reusable.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -30 and 50 Degrees Celsius
Storage Environment Temperature: between -22 and 122 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8362eabc-2205-4051-927b-071c25adc813
Public Version Date: June 06, 2024
Public Version Number: 7
DI Record Publish Date: April 21, 2020