Duns Number:314101143
Device Description: IntelliVue NMT Hand Adapter for use with IntelliVue NMT Patient Cable 989803174581 and Int IntelliVue NMT Hand Adapter for use with IntelliVue NMT Patient Cable 989803174581 and IntelliVue Neuro Muscular Transmission Module 865383. Adapter is reusable. 1 Sales Unit = 10 each
Catalog Number
989803199211
Brand Name
NA
Version/Model Number
IntelliVue NMT Hand-Adapter
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
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
1ac5be08-529c-4b50-b776-395863b86c22
Public Version Date
April 06, 2022
Public Version Number
5
DI Record Publish Date
August 21, 2019
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |