Lightning X

GUDID 16946430421583

Single patient use manual resuscitator for use in 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: 16946430421583
• NIH Device Record Key: 2739f541-0b9a-404f-96b7-ac405ab27903
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning X
• Version Model Number: NPVC-003/RTMA1
• 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	06946430421586 [Primary]
GS1	16946430421583 [Package]; Contains: 06946430421586; 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: 2024-10-03
• Device Publish Date: 2024-09-25

On-Brand Devices [Lightning X]

• 06946430421579: Single patient use manual resuscitator for use in hospital,transport,emergency,and post hospital
• 16946430421583: Single patient use manual resuscitator for use in hospital,transport,emergency,and post hospital