VYGON - 35" STANDARDBORE PIGGYBACK SECONDARY ADMIN. SET - Vygon Corporation

Duns Number:120818216

Device Description: 35" STANDARDBORE PIGGYBACK SECONDARY ADMIN. SET W/UNIVERSAL DRIP CHAMBER & SPIKE

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More Product Details

Catalog Number

AMS-184-1

Brand Name

VYGON

Version/Model Number

AMS-184-1

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

K884370,K884370

Product Code Details

Product Code

FPK

Product Code Name

Tubing, fluid delivery

Device Record Status

Public Device Record Key

5a38aa08-f880-413e-802f-7fa1cc236d88

Public Version Date

November 22, 2019

Public Version Number

1

DI Record Publish Date

November 14, 2019

Additional Identifiers

Package DI Number

30849884000260

Quantity per Package

50

Contains DI Package

00849884000269

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