Duns Number:790605856
Device Description: MX40 Adapter 5-Lead + Masimo SpO2. For use with MX Telemetry systems. Supports IntelliVue MX40 Adapter 5-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. 5 lead ECG + Masimo SET SpO2. Quantity 1, reusable.
Catalog Number
989803202381
Brand Name
MX40 Masimo Leadsets and Adapters
Version/Model Number
MX40 Adapter 5-Lead + Masimo SpO2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHX
Product Code Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Public Device Record Key
87fab46b-bb35-4452-98af-2925f3e209ac
Public Version Date
May 31, 2022
Public Version Number
1
DI Record Publish Date
May 23, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |