Catalog Number

M09-0000-0000

Brand Name

Medviron

Version/Model Number

Guardian Rise II Bassinet

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NZG

Product Code Name

Bassinet, Hospital

Public Device Record Key

825bba2d-81dd-44be-bdd8-7cc315e3e0b8

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

October 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-