Catalog Number

210

Brand Name

Ameritus

Version/Model Number

210

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

Yes

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

K960080,K960080

Product Code

FMT

Product Code Name

Warmer, Infant Radiant

Public Device Record Key

3f2c69a4-92c8-4902-b6e9-d99789b8b1d0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 02, 2016

Package DI Number

20817522010028

Quantity per Package

10

Contains DI Package

10817522010021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box