Duns Number:639571707
Device Description: Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyogr Neuromuscular blocking agent monitoring cable (3.5 m) with three dimensional acceleromyography.
Catalog Number
XT-45025A
Brand Name
Xavant Technology
Version/Model Number
NMBA Cable with Accelerometer (3.5m)
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
K102084,K102084,K102084,K102084,K102084
Product Code
BXN
Product Code Name
Stimulator, Nerve, Battery-Powered
Public Device Record Key
1b0c8ebb-1af7-49b6-ac92-bd0117542ed2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 30, 2018
Package DI Number
46009880396342
Quantity per Package
2
Contains DI Package
36009880396345
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |