Rescuer II Compact CPAP System

Basic Information

• Brand Name: Rescuer II Compact CPAP System
• Primary DI: B00288100
• Version / Model: 8810
• Catalog Number: 8810
• Company Name: B.L.S. Systems Limited
• Labeler DUNS: 200103823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-05
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d40e1f5b-ff34-4645-9bf5-4b89f0fe5487

Device Description

Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. This is a disposable CPAP mask (Model 8810 is the small mask with pre-attached bonnet). This device is intended for patients exhibiting signs of respiratory distress.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57813	CPAP/BPAP face mask, single-use	A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B00288101	HIBCC	Case of 6	6	In Commercial Distribution
Primary	B00288100	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K122610	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Small CPAP Mask

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -15 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius