MENDYOUMEDICAL

GUDID 16946430421941

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: 16946430421941
• NIH Device Record Key: 13a9bbad-47b9-419e-b1a4-2b56dfc5556a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENDYOUMEDICAL
• 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	06946430421944 [Primary]
GS1	16946430421941 [Package]; Contains: 06946430421944; 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: 2024-12-04
• Device Publish Date: 2024-11-26

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

• 16946430423259 - Compower: 2025-03-26 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
• 16946430423266 - Compower: 2025-03-26 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
• 06946430423276 - Compower: 2025-03-26 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
• 16946430423280 - Compower: 2025-03-26 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
• 16946430423297 - Compower: 2025-03-26 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
• 16946430423303 - Compower: 2025-03-26 Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air
• 16946430423310 - Compower: 2025-03-26 Headgear is designed to fit the mask over the patient 's hand.
• 16946430423327 - Compower: 2025-03-26 Headgear is designed to fit the mask over the patient's head.