V8800 Critical Care Ventilator - Critical Care Ventilator with standard features - ORICARE INC.

Duns Number:009527042

Device Description: Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Spanish Lan Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. Spanish Language. USA Power Setup

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More Product Details

Catalog Number

0081508502032

Brand Name

V8800 Critical Care Ventilator

Version/Model Number

V8800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K120931

Product Code Details

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Device Record Status

Public Device Record Key

f4830bfd-6b34-44a8-897d-211e9fe17a22

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORICARE INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 44