Lightning X Products, Inc

GUDID 16946430413663

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

• Primary Device ID: 16946430413663
• NIH Device Record Key: 9daa4659-a6ad-4aad-bc4e-bd2eb01c454c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning X Products, Inc
• 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	06946430413666 [Primary]
GS1	16946430413663 [Package]; Contains: 06946430413666; 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: 2022-05-09
• Device Publish Date: 2022-04-30

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

• 16946430421804 - MFASCO: 2024-12-04 Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port and two pieces alcohol pads. CPR Mask with Oxygen Port is d
• 16946430421941 - MENDYOUMEDICAL: 2024-12-04 CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emerge
• 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