EMI

GUDID 16946430413649

Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg

XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use

• Primary Device ID: 16946430413649
• NIH Device Record Key: 4381f392-acd0-4896-9713-f00a3e873203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMI
• Version Model Number: NPVC-001/RTMA
• 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	06946430413642 [Primary]
GS1	16946430413649 [Package]; Contains: 06946430413642; Package: carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210288

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2022-03-28
• Device Publish Date: 2022-03-19

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