Mini Cradle with Splitter- US - Q-CORE MEDICAL LTD

Duns Number:533108028

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More Product Details

Catalog Number

17000-026-0007

Brand Name

Mini Cradle with Splitter- US

Version/Model Number

17000-026-0007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2016

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)

Yes

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

7ab000d0-f9e1-4b6e-845c-224ebd6c2b69

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 07, 2016

Additional Identifiers

Package DI Number

27290109150011

Quantity per Package

20

Contains DI Package

17290109150014

Package Discontinue Date

October 23, 2016

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