Universal Y Connector - Universal Y Connector - GENESEE BIOMEDICAL, INC.

Duns Number:939872651

Device Description: Universal Y Connector

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More Product Details

Catalog Number

-

Brand Name

Universal Y Connector

Version/Model Number

WD-20

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

ff971703-9321-4d7c-b9ea-e49a88116e37

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

February 01, 2017

Additional Identifiers

Package DI Number

B040WD202J

Quantity per Package

1

Contains DI Package

B040WD201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GENESEE BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 53