BioVac - The disposable BioVac direct suction device is - US Endoscopy

Duns Number:627879687

Device Description: The disposable BioVac direct suction device is indicated for transendoscopic evacuation, d The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or fluid, such as residual stool, within the gastrointestinal tract through the biopsy/suction channel of flexible gastrointestinal endoscopes. It also provides access for endoscopic device passage and exchange, and allows for supplemental intraprocedural irrigation when desired.

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More Product Details

Catalog Number

00711511

Brand Name

BioVac

Version/Model Number

00711511

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2020

Issuing Agency

In GS1

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"

Yes

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

KQT

Product Code Name

EVACUATOR, GASTRO-UROLOGY

Device Record Status

Public Device Record Key

b3e52d49-7ca4-4877-9655-3133c346a6a9

Public Version Date

November 03, 2020

Public Version Number

2

DI Record Publish Date

April 01, 2020

Additional Identifiers

Package DI Number

10724995183780

Quantity per Package

5

Contains DI Package

00724995183783

Package Discontinue Date

November 02, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902