CAREvent ALS 01CV3000

GUDID 07540195025165

CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individual

O-Two Medical Technologies Inc

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 07540195025165
• NIH Device Record Key: fd84b9ed-9559-4528-97bd-a6d96183c79c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAREvent ALS
• Version Model Number: 01CV3000
• Catalog Number: 01CV3000
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com

Device Dimensions

• Weight: 0.45 Kilogram
• Height: 2.9 Inch
• Width: 2.5 Inch
• Length: 5.5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195025158 [Direct Marking]
GS1	07540195025165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991195

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-26

On-Brand Devices [CAREvent ALS]

• 07540195025165: CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled venti
• 07540195025141: CAREvent ALS kit 01CV3212 contains a CAREvent ALS resuscitator, a pressure regulator, and an asp
• 07540195025134: CAREvent ALS kit 01CV3200 contains a CAREvent ALS resuscitator and a pressure regulator in a car
• 07540195025127: CAREvent ALS kit 01CV3112 contains a CAREvent ALS resuscitator, a pressure regulator, and an asp
• 07540195025110: CAREvent ALS kit 01CV3100 contains a CAREvent ALS resuscitator and a pressure regulator. CAREven