Multi-Pump Mounting System kit single pack for US - Q-CORE MEDICAL LTD

Duns Number:533108028

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More Product Details

Catalog Number

17000-020-0008

Brand Name

Multi-Pump Mounting System kit single pack for US

Version/Model Number

17000-020-0008

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2017

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

K123049,K123049,K123049

Product Code Details

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Device Record Status

Public Device Record Key

1cc92aea-f977-487a-9d4f-283a756c9edd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

27290109150097

Quantity per Package

4

Contains DI Package

17290109150090

Package Discontinue Date

March 03, 2017

Package Status

Not in Commercial Distribution

Package Type

cardboard box

"Q-CORE MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65