ZephyrLIFE Hospital - ZephyrLIFE Hospital Application Software - ZEPHYR TECHNOLOGY LLC

Duns Number:796678527

Device Description: ZephyrLIFE Hospital Application Software Application?

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More Product Details

Catalog Number

Software Hospital

Brand Name

ZephyrLIFE Hospital

Version/Model Number

Software Hospital

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)

Yes

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

DRG

Product Code Name

TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Device Record Status

Public Device Record Key

bdeab43d-d1ce-4cf9-bd16-b14c64075a06

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZEPHYR TECHNOLOGY LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16