Duns Number:790605856
Device Description: ECG 5L Grabber, AAMI, Masimo SpO2, Tele. MX40 Patient Cable consists of 5-wire ECG lead se ECG 5L Grabber, AAMI, Masimo SpO2, Tele. MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin Masimo SET SpO2 connector cable. Grabber leads, AAMI color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5"). 1 Sales unit = 1 cable.
Catalog Number
989803202411
Brand Name
MX40 Masimo Leadsets and Adapters
Version/Model Number
ECG 5L Grabber, AAMI, Masimo SpO2 , Tele
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
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
9d3733a1-9319-4eb6-ba4c-4f40783327e3
Public Version Date
March 04, 2022
Public Version Number
5
DI Record Publish Date
April 21, 2020
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 |