Duns Number:435827526
Device Description: 2.101129 Trolley X1 - base only
Catalog Number
SC_X1
Brand Name
MULTIX SOLUTIONS SRL
Version/Model Number
X1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZN
Product Code Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Public Device Record Key
e48dc435-acbf-4c1f-9b55-ebf3f35ac654
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
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 | 69 |