CAREvent ALS+ - CAREvent ALS+ is intended to provide artificial - O-Two Medical Technologies Inc

Duns Number:206449154

Device Description: CAREvent ALS+ is intended to provide artificial ventilation for patients during respirator CAREvent ALS+ is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneous adjustment of ventilation frequency and tidal volume has 12 settings for a range of patients from 20 kg body weight to large adults. A separate Manual/Automatic control allows the operator to turn off the automatic cycling and ventilate the patient manually. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. CAREvent ALS+ also includes an airway Pressure Gauge and pneumatic alarm for Low Pressure Input Pressure. It also allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.

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More Product Details

Catalog Number

01CV4000

Brand Name

CAREvent ALS+

Version/Model Number

01CV4000

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

K991195,K991195

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

2391bc0f-c514-4d4b-bd9e-6be4069865f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"O-TWO MEDICAL TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 48
U Unclassified 3