MULTIX SOLUTIONS SRL - 2.101214 MULTIFUNCTIONAL TROLLEY FOR CARDIOPULSE - MULTIX SOLUTIONS SRL

Duns Number:435827526

Device Description: 2.101214 MULTIFUNCTIONAL TROLLEY FOR CARDIOPULSE PRIME

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More Product Details

Catalog Number

SC_2.101214

Brand Name

MULTIX SOLUTIONS SRL

Version/Model Number

X1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZN

Product Code Name

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Device Record Status

Public Device Record Key

d1f778af-f999-409d-b6f8-186a51ae3b25

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MULTIX SOLUTIONS SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 69