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

• 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.