APmedical - (8 Gal CHEMO USA YELL Disposable Container - ABM ITALIA SPA

Duns Number:338493631

Device Description: (8 Gal CHEMO USA YELL Disposable Container w/Port/Duo Lid) Single EA

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

APmedical

Version/Model Number

FGSC30DYC001 SC30DY

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

K071517

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

50056995-d334-41fa-871c-831c278caefa

Public Version Date

November 06, 2019

Public Version Number

4

DI Record Publish Date

February 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABM ITALIA SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 92