SpiroDef

GUDID 07613365500110

SpiroDef Mouthpiece

Ganshorn Medizin Electronic GmbH

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 07613365500110
• NIH Device Record Key: 01068c7c-2083-4f9d-bc0c-5a082abfa2a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroDef
• Version Model Number: A
• Company DUNS: 318498177
• Company Name: Ganshorn Medizin Electronic GmbH
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	07613365500110 [Unit of Use]
GS1	07613365500127 [Primary]

FDA Product Code

• BYP: Mouthpiece, Breathing

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: 2024-12-30
• Device Publish Date: 2024-12-20

On-Brand Devices [SpiroDef]

• 07613365500196: SpiroDef (Mouthpiece) with NoseClip
• 07613365500134: SpiroDef ScoutTube
• 07613365500110: SpiroDef Mouthpiece