Catalog Number

11475-010

Brand Name

PORTA-WARM

Version/Model Number

11475-010

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Public Device Record Key

10d89ca6-8783-421b-aeda-9ee1fc78893a

Public Version Date

March 31, 2020

Public Version Number

2

DI Record Publish Date

May 30, 2019

Package DI Number

50630140017498

Quantity per Package

1

Contains DI Package

00630140017493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE