Silicone Vac Drain Kit +J connector - FORTUNE MEDICAL INSTRUMENT CORP.

Duns Number:656763489

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More Product Details

Catalog Number

-

Brand Name

Silicone Vac Drain Kit +J connector

Version/Model Number

2014-9421J

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

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

GCD

Product Code Name

Connector, Catheter

Device Record Status

Public Device Record Key

6035b0c4-35c9-4cca-8cd5-f40d65de9939

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

January 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORTUNE MEDICAL INSTRUMENT CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 307
2 A medical device with a moderate to high risk that requires special controls. 3