MEDICAL SPECIALTIES - FILTER AND FLUID CONNECTOR KIT - Vygon Corporation

Duns Number:120818216

Device Description: FILTER AND FLUID CONNECTOR KIT

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More Product Details

Catalog Number

MSPT-010878

Brand Name

MEDICAL SPECIALTIES

Version/Model Number

MSPT-010878

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

-

Product Code Details

Product Code

OJA

Product Code Name

Intravenous extension tubing set

Device Record Status

Public Device Record Key

d1e3f2dd-223d-4c48-a187-3f0e5786c498

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

38498840006871

Quantity per Package

50

Contains DI Package

08498840006870

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