Rescuer Emergency CPAP with Medium CPAP Mask

Basic Information

• Brand Name: Rescuer Emergency CPAP with Medium CPAP Mask
• Primary DI: B0028705NK0
• Version / Model: 8705-NK
• Catalog Number: 8705-NK
• 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: 2020-01-06
• Public Version: 2
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 4e5c2e67-7a79-486f-8f6c-3ec824edfb63

Device Description

Rescuer Emergency CPAP with Medium CPAP Mask and Nebulizer Kit (8900)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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	B0028705NK1	HIBCC	Case	6	In Commercial Distribution
Primary	B0028705NK0	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			Medium CPAP Mask

Storage Conditions

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