Sunflower Warmer, Wall Mount AC120V - ATOM MEDICAL CORPORATION

Duns Number:690632047

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More Product Details

Catalog Number

61577

Brand Name

Sunflower Warmer, Wall Mount AC120V

Version/Model Number

61577

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

a275eac0-75ca-483b-9389-0366eeeba6b1

Public Version Date

January 29, 2019

Public Version Number

3

DI Record Publish Date

December 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATOM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 40