HEATING ELEMENT 560W-120V - Heating Element Only - RPI

Duns Number:066232067

Device Description: Heating Element Only

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More Product Details

Catalog Number

AIH039

Brand Name

HEATING ELEMENT 560W-120V

Version/Model Number

AIH039

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMT

Product Code Name

Warmer, Infant Radiant

Device Record Status

Public Device Record Key

df6d2830-081d-4bc8-9442-b571f7bffa81

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RPI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 131