EMI

GUDID 16946430414370

It contain one non-rebreathing valve. The non-rebreathing valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the counter-use.

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

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: 16946430414370
• NIH Device Record Key: f4dfe305-9638-4313-9ddc-6ec9a47cbd66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMI
• Version Model Number: CP646003
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946430414373 [Primary]
GS1	16946430414370 [Package]; Contains: 06946430414373; Package: carton [400 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: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [EMI]

• 16946430413656: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital
• 16946430413649: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital
• 16946430414370: It contain one non-rebreathing valve. The non-rebreathing valve is a single-use, non-sterile dev
• 16946430414363: The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces