Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit

Basic Information

• Brand Name: Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit
• Primary DI: B0028805NK0
• Version / Model: 8805-NK
• Catalog Number: 8805-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: 2018-10-02
• Public Version: 1
• Public Version Date: 2018-11-02
• Public Version Status: New
• Public Device Record Key: e15511e8-0ac9-4518-a2f3-05e2c98ff754

Device Description

Rescuer II Compact CPAP with Medium Deluxe CPAP Mask and Nebulizer Kit

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
61656	In-line CPAP set, nebulizing	A portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a face mask, a nebulizer, and may include additional components (e.g., manometer, flowmeter, tubing, mask strap). This is a reusable device once the consumable products have been replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B0028805NK1	HIBCC	Case	6	In Commercial Distribution
Primary	B0028805NK0	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

Storage Conditions

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