JOHN BUNN

GUDID M368JB01121101

Neb-u-Lite LX Nebulizer Compressor

GF HEALTH PRODUCTS, INC.

Benchtop nebulizer, non-heated

• Primary Device ID: M368JB01121101
• NIH Device Record Key: ed8b213f-2216-46bb-b69c-53404fc786b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOHN BUNN
• Version Model Number: JB0112-110
• Company DUNS: 132016168
• Company Name: GF HEALTH PRODUCTS, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M368JB01121101 [Primary]
HIBCC	M368JB01121102 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161586

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-08-31

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