Remedium International LLC

GUDID 00860456000913

REMEDIUM INTERNATIONAL LLC

Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 00860456000913
• NIH Device Record Key: 4654ebfd-e014-469e-b62d-8fced1196769
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedium International LLC
• Version Model Number: JLN-2320 AS
• Company DUNS: 081019576
• Company Name: REMEDIUM INTERNATIONAL LLC
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860456000913 [Primary]

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2018-04-30
• Device Publish Date: 2018-03-29

On-Brand Devices [Remedium International LLC]

• 00860456000937: JLN-2300 AS
• 00860456000920: JLN-2305 BS
• 00860456000913: JLN-2320 AS