Bunnell

GUDID 10616120000089

LifePulse High Frequency Ventilator - Patient Circuit with LifePort Adapters (2.5, 3.0, 3.5) Kit

BUNNELL, INCORPORATED

Stationary electric high-frequency ventilator Stationary electric high-frequency ventilator

• Primary Device ID: 10616120000089
• NIH Device Record Key: 10044311-7573-439e-af3c-a97e46597aaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bunnell
• Version Model Number: 903
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	00616120000082 [Primary]
GS1	10616120000089 [Package]; Contains: 00616120000082; Package: [2 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-30

On-Brand Devices [Bunnell]

• 10616120000089: LifePulse High Frequency Ventilator - Patient Circuit with LifePort Adapters (2.5, 3.0, 3.5) Kit
• 00616120000020: LifePulse High Frequency Ventilator - Patient Circuit with LifePort Adapters Kit