GENOSS Inflator B30

GUDID 08800026507598

GENOSS CO., Ltd.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 08800026507598
• NIH Device Record Key: c06ab92a-1f98-4b9e-a9e9-2bddf5bf16f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENOSS Inflator B30
• Version Model Number: GBI-B30S
• Company DUNS: 690083006
• Company Name: GENOSS CO., Ltd.
• Device Count: 1
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08800026507598 [Primary]

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-26
• Device Publish Date: 2024-06-18

On-Brand Devices [GENOSS Inflator B30]

• 08809324765433: GBI-30V
• 08800026530329: GBI-B30
• 08800026507598: GBI-B30S
• 08800026501565: GBI-30
• 08800026501558: GBI-B30