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

October 31, 2025

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"

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

a8c87a8f-69bb-4e72-b796-a3b931eeae3a

Public Version Date

June 06, 2022

Public Version Number

3

DI Record Publish Date

September 07, 2016

Additional Identifiers

Package DI Number

H862TVOCP2

Quantity per Package

10

Contains DI Package

H862TVOCP1

Package Discontinue Date

October 31, 2025

Package Status

In Commercial Distribution

Package Type

Shipper

"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