Catalog Number

-

Brand Name

Isolette® 8000 plus

Version/Model Number

MU20602

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172154

Product Code

FMZ

Product Code Name

Incubator, Neonatal

Public Device Record Key

3fd42f2c-db0e-4230-9c23-9fef3fac8679

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-