Rescuer Emergency CPAP System 8755

GUDID B00287551

Rescuer Emergency CPAP System with #4 Cushion Mask and silicone head strap used for patients exhibiting acute episodes of respiratory distress.

B.L.S. Systems Limited

CPAP/BPAP face mask, single-use

• Primary Device ID: B00287551
• NIH Device Record Key: 659d901b-b327-4a57-81ab-1e7984ffe247
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescuer Emergency CPAP System
• Version Model Number: 8755
• Catalog Number: 8755
• Company DUNS: 200103823
• Company Name: B.L.S. Systems Limited
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 905 3391069
• Email: tedreesor@blssystemsltd.com
• Phone: 905 3391069
• Email: tedreesor@blssystemsltd.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00287550 [Primary]
HIBCC	B00287551 [Package]; Contains: B00287550; Package: Case of 6 [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122610

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-05

On-Brand Devices [Rescuer Emergency CPAP System]

• B20087101: Rescuer Emergency CPAP Systems with small CPAP mask and pre-attached bonnet is a single patient
• B00287551: Rescuer Emergency CPAP System with #4 Cushion Mask and silicone head strap used for patients exh
• B20087501: Rescuer Emergency CPAP System with #6 cushion mask and silicone head strap used to deliver conti
• B00287050: Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute
• B00287001: Rescuer Emergency CPAP System is a disposable CPAP generator with CPAP mask and pre-attached bon