Rescuer II Compact CPAP System with Medium Deluxe 8805-NK

GUDID B0028805NK1

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

B.L.S. Systems Limited

In-line CPAP set, nebulizing In-line CPAP set, nebulizing

• Primary Device ID: B0028805NK1
• NIH Device Record Key: e15511e8-0ac9-4518-a2f3-05e2c98ff754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescuer II Compact CPAP System with Medium Deluxe
• Version Model Number: 8805-NK
• Catalog Number: 8805-NK
• 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: 9053361069
• Email: tedreesor@blssystemsltd.com
• Phone: 9053361069
• 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	B0028805NK0 [Primary]
HIBCC	B0028805NK1 [Package]; Contains: B0028805NK0; Package: Case [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-02
• Device Publish Date: 2018-10-02

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