Spiracle Technology

GUDID 16946430415391

CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 16946430415391
• NIH Device Record Key: e013669c-e512-47bd-988e-f6927c0213cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiracle Technology
• Version Model Number: CP641000
• Company DUNS: 543482946
• Company Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946430415394 [Primary]
GS1	16946430415391 [Package]; Contains: 06946430415394; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171961

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: 2023-06-23
• Device Publish Date: 2023-06-15

Devices Manufactured by XIAMEN COMPOWER MEDICAL TECH. CO., LTD

• 16946430421583 - Lightning X: 2024-10-03 Single patient use manual resuscitator for use in hospital,transport,emergency,and post hospital care to temporary ventilate a p
• 06946430421579 - Lightning X: 2024-09-26 Single patient use manual resuscitator for use in hospital,transport,emergency,and post hospital care to temporary ventilate a p
• 06946430421500 - ODRESCUE: 2024-09-09 CPR Mask is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator(CPR) res
• 16946430419900 - WNLProducts: 2024-07-08 CPR Mask is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator(CPR) res
• 06946430401618 - Aquatic Solutions: 2024-04-03 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pa
• 16946430401806 - Ever Ready First Aid: 2024-04-03 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pa
• 16946430414844 - Inkwell Global Marketing: 2024-04-03 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pa
• 16946430416107 - FIRST AID ONLY: 2023-11-27 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, two pieces alcohol pads and one pair Nitril glove. CPR Mas