CAREvent ALS

Primary DI
07540195025127
Brand
CAREvent ALS
Company
O-Two Medical Technologies Inc
Model
01CV3112
Catalog number
01CV3112
Device description
CAREvent ALS kit 01CV3112 contains a CAREvent ALS resuscitator, a pressure regulator, and an aspirator in moulded case with a Yankauer Scution Tip with Tubing.CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent ALS delivers automatic ventilation with controlled flow rates, airway pressure, tidal volume and frequencies. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
Published
2015-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991195000CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATVO-Two Systems Intl., Inc.1999-04-22BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540195025127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540195025127075401950251277540195025127

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, pneumatic, reusableA device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a breathing circuit with, e.g., a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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