Sunmed Inflation devices

GUDID 06947358563402

Sunny Medical Device (Shenzhen) Co., Ltd.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 06947358563402
• NIH Device Record Key: 20f7d66b-081b-489c-b235-7ea82c7a4c58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunmed Inflation devices
• Version Model Number: S-type, 30ml, 40atm/bar
• Company DUNS: 529639795
• Company Name: Sunny Medical Device (Shenzhen) Co., Ltd.
• 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: false
• 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	06947358563402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133795

FDA Product Code

• MAV: Syringe, Balloon Inflation

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: 2023-10-03
• Device Publish Date: 2023-09-25

Devices Manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.

• 06947358535539 - Sunmed™ guide wires: 2024-01-15
• 06947358563402 - Sunmed Inflation devices: 2023-10-03
• 06947358563402 - Sunmed Inflation devices: 2023-10-03
• 06947358546719 - Sunmed Haemostatic Valves: 2023-07-14
• 06947358571698 - Sunmed disposable needles: 2023-07-14
• 06947358582618 - Sunmed disposable angio-closure pads: 2023-07-14
• 06947358544302 - Sunmed guidewire torque device: 2022-01-12
• 06947358566007 - Sunmed Inflation Device: 2022-01-12
• 06947358568001 - Sunmed Inflation Device: 2022-01-12