VYGON - 10" LIFEGUARD SAFETY INFUSION SET WITH 20 GA. X - Vygon Corporation

Duns Number:120818216

Device Description: 10" LIFEGUARD SAFETY INFUSION SET WITH 20 GA. X .5" HUBER NEEDLE

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More Product Details

Catalog Number

CLG-2050

Brand Name

VYGON

Version/Model Number

CLG-2050

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"

-

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

K013871,K013871,K013871

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

e84225cf-b00d-4e6f-9a01-7719f499738f

Public Version Date

April 01, 2020

Public Version Number

1

DI Record Publish Date

March 24, 2020

Additional Identifiers

Package DI Number

50849884003814

Quantity per Package

18

Contains DI Package

30849884003810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYGON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 833