MIVI High Flow Tubing - MIVI High Flow Tubing is to be used with an - MIVI NEUROVASCULAR

Duns Number:076836823

Device Description: MIVI High Flow Tubing is to be used with an external source of vacuum to aspirate, remove, MIVI High Flow Tubing is to be used with an external source of vacuum to aspirate, remove, or sample body fluids.

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More Product Details

Catalog Number

-

Brand Name

MIVI High Flow Tubing

Version/Model Number

HFT110

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

Yes

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Device Record Status

Public Device Record Key

c147efa2-586d-496b-91db-e810954c98a2

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

January 05, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIVI NEUROVASCULAR" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20