FLY

GUDID 06971082850088

Shanghai FLY Medical Devices Co., Ltd.

Endoscope inflation bulb

• Primary Device ID: 06971082850088
• NIH Device Record Key: dde59f66-5af3-428c-84f8-80abcb3eb8b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLY
• Version Model Number: FLY-BT-102
• Company DUNS: 544492194
• Company Name: Shanghai FLY Medical Devices 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: false
• 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	06971082850088 [Primary]
GS1	16971082850153 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• FCY: Bulb, Inflation, For Endoscope

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: 2023-04-06
• Device Publish Date: 2023-03-29