LifePulse

GUDID 00616120000006

LifePulse High Frequency Ventilator Model 203A

BUNNELL, INCORPORATED

Stationary electric high-frequency ventilator

• Primary Device ID: 00616120000006
• NIH Device Record Key: f9da9888-1c6e-4e4f-96dc-fc47b4d9ca18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifePulse
• Version Model Number: 203A
• Company DUNS: 023869365
• Company Name: BUNNELL, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00616120000006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850064

FDA Product Code

• LSZ: Ventilator, High Frequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-28
• Device Publish Date: 2014-09-24

On-Brand Devices [LifePulse]

• 00616120000112: LifePulse High Frequency Ventilator - Patient Box Model 314
• 00616120000105: LifePulse High Frequency Ventilator Model 204
• 00616120000013: LifePulse High Frequency Ventilator - Patient Box Model 312
• 00616120000006: LifePulse High Frequency Ventilator Model 203A