Rescuer 3000-X

GUDID B0023000X7

Rescuer CPR Shield with gloves

B.L.S. Systems Limited

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

• Primary Device ID: B0023000X7
• NIH Device Record Key: 9bdc97ad-7496-4a17-b9e7-c1ebd458c0bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescuer
• Version Model Number: 3000-X
• Catalog Number: 3000-X
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 1 905 339 1069
• Email: tedreesor@blssystemsltd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0023000X0 [Primary]
HIBCC	B0023000X7 [Package]; Contains: B0023000X0; Package: Bag [50 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

On-Brand Devices [Rescuer]

• B0024000F0: HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
• B0023000X7: Rescuer CPR Shield with gloves