BILI-THERAPY Spot Type / Stand Type AC100-240V - ATOM MEDICAL CORPORATION

Duns Number:690632047

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More Product Details

Catalog Number

60360

Brand Name

BILI-THERAPY Spot Type / Stand Type AC100-240V

Version/Model Number

60360

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

LBI

Product Code Name

Unit, Neonatal Phototherapy

Device Record Status

Public Device Record Key

22111519-00a0-49e8-ae28-1efd3031c352

Public Version Date

January 29, 2019

Public Version Number

3

DI Record Publish Date

September 21, 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