E-Z Draw - Sample Port - REPROCESSING PRODUCTS CORPORATION

Duns Number:796083392

Device Description: Sample Port

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More Product Details

Catalog Number

-

Brand Name

E-Z Draw

Version/Model Number

D300-2012

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

-

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

MON

Product Code Name

System, Hemodialysis, Remote Accessories

Device Record Status

Public Device Record Key

e9b650ec-4a86-4eca-a3b1-4ecfa00da768

Public Version Date

October 21, 2020

Public Version Number

1

DI Record Publish Date

October 13, 2020

Additional Identifiers

Package DI Number

00858293006830

Quantity per Package

1000

Contains DI Package

00858293006359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"REPROCESSING PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 46