Catalog Number

43101

Brand Name

Argyle

Version/Model Number

43101

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

-

Product Code

FMT

Product Code Name

WARMER, INFANT RADIANT

Public Device Record Key

d9d37df3-f043-41d2-b54b-5e41fb90486c

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884527006557

Quantity per Package

200

Contains DI Package

20884527006554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE