Catalog Number

15042-000-0010

Brand Name

Mini Cradle - US

Version/Model Number

15042-000-0010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2016

Issuing Agency

In GS1

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

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

0a552bb2-5d45-4e13-a5ae-8dbe07c06032

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 04, 2016

Package DI Number

27290109150004

Quantity per Package

20

Contains DI Package

17290109150007

Package Discontinue Date

October 23, 2016

Package Status

Not in Commercial Distribution

Package Type

cardboard box