AccessGUDID - DEVICE: CAFREvent ALS+ CPAP (07540195025325)

GUDID

Device Identifier (DI) Information

Brand Name: CAFREvent ALS+ CPAP
Version or Model: 01CV4000-CPAP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01CV4000-CPAP
Company Name: O-Two Medical Technologies Inc

Primary DI Number: 07540195025325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206449154 *Terms of Use

Device Description: CAREvent ALS+ CPAP 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+ CPAP 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. In addition, CAREvent ALS+ CPAP has an adjustable CPAP/PEEP mode, eliminating the need for an external PEEP valve or CPAP device.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13366	Pulmonary resuscitator, pneumatic, reusable	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTL	Ventilator, Emergency, Powered (Resuscitator)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991195	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1.5 Kilogram
Height: 2.95 Inch
Width: 5.5 Inch
Length: 8.1 Inch

Device Record Status

Public Device Record Key: 48cafaa6-1640-4901-858a-ee80b1fc92bd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 26, 2015