Facemask with O2, headstrap and one way valve 2025-HS

GUDID B0022025HS0

Rescuer disposable CPR mask with oxygen inlet, head strap and one way valve

B.L.S. Systems Limited

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: B0022025HS0
• NIH Device Record Key: b2d1dc6a-2eff-4042-a5fc-50cb65708a41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facemask with O2, headstrap and one way valve
• Version Model Number: 2025-HS
• Catalog Number: 2025-HS
• 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: 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 905 339 1069
• Email: tedreesor@blssystemsltd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0022025HS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010191

FDA Product Code

• CBP: Valve, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

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