Micro-Vent 177-107

GUDID 00718175001073

Micro-Vent Radioaerosol System

BIODEX MEDICAL SYSTEMS, INC.

Radioaerosol administration set

• Primary Device ID: 00718175001073
• NIH Device Record Key: 080788a2-d6ba-4c55-8221-14f4d6d3124a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-Vent
• Version Model Number: 177-107
• Catalog Number: 177-107
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, 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: true
• Lot Batch: true
• Serial Number: false
• 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	00718175001073 [Primary]
GS1	10718175001087 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	20718175001091 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	30718175001104 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904717

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-16

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