Thora-Vent Thoracic Vent - Thoracic Vent Occlusion Plug - URESIL, LLC

Duns Number:192559557

Device Description: Thoracic Vent Occlusion Plug

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More Product Details

Catalog Number

TVOCP

Brand Name

Thora-Vent Thoracic Vent

Version/Model Number

TVOCP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2027

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

a25e7e24-928d-4626-90d2-6ceaf794a3cc

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

June 03, 2022

Additional Identifiers

Package DI Number

10817640020797

Quantity per Package

5

Contains DI Package

00817640020790

Package Discontinue Date

July 01, 2027

Package Status

Not in Commercial Distribution

Package Type

Dispenser

"URESIL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 179
2 A medical device with a moderate to high risk that requires special controls. 77
U Unclassified 24