Facemask with one way valve in hard shell carrying 2025

GUDID B002000CC0

Rescuer disposable CPR mask with one way valve in hard shell carrying case

B.L.S. Systems Limited

Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: B002000CC0
• NIH Device Record Key: a26e2962-1011-46dc-80b7-43ad68eb5b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facemask with one way valve in hard shell carrying
• Version Model Number: 2025
• Catalog Number: 2025
• 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@blssystyemsltd.com
• Phone: 905 339 1069
• Email: tedreesor@blssystyemsltd.com

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	B002000CC0 [Primary]
HIBCC	B0022000CC8 [Package]; Package: Case of 100 [100 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

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