American Red Cross

GUDID 16946430410327

Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, one piece alcohol pad and one pair Nitrile glove. 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. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for Rx only and for infants with body weight up to 10kg (22 lbs).

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Cardiopulmonary resuscitation kit, single-use

• Primary Device ID: 16946430410327
• NIH Device Record Key: fb42053b-3faf-419d-abcd-1e92ec0f7b43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: American Red Cross
• Version Model Number: CP641000+CP641007+1A+NG
• 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: true
• 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	06946430410320 [Primary]
GS1	16946430410327 [Package]; Contains: 06946430410320; Package: carton [100 Units]; In Commercial Distribution

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: 2020-04-08
• Device Publish Date: 2020-03-31

On-Brand Devices [American Red Cross]

• 16946430410273: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without O
• 16946430410327: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Ox
• 16946430410303: Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Ox