115E-H-A - ELECTRONIC YOUTH BED - NOVUM MEDICAL PRODUCTS INC

Duns Number:066412472

Device Description: ELECTRONIC YOUTH BED

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More Product Details

Catalog Number

-

Brand Name

115E-H-A

Version/Model Number

115E-H-A

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

FMS

Product Code Name

Bed, Pediatric Open Hospital

Device Record Status

Public Device Record Key

a9b84e38-7e0c-4255-8d53-3c70b9b82d95

Public Version Date

February 03, 2020

Public Version Number

1

DI Record Publish Date

January 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVUM MEDICAL PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 87