GENOSS Inflator B40

GUDID 08800026507635

GENOSS CO., Ltd.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 08800026507635
• NIH Device Record Key: 2d1d072b-ea9c-4099-8ef0-92860203ca97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENOSS Inflator B40
• Version Model Number: GBI-B40VS
• 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	08800026507635 [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 B40 ]

• 08809552962925: GBI-B40
• 08809552962918: GBI-B40
• 08800026512752: GBI-B40S
• 08800026507635: GBI-B40VS
• 08800026507611: GBI-B40V