Sunmed Inflation Device

GUDID 06947358563006

Sunny Medical Device (Shenzhen) Co., Ltd.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 06947358563006
• NIH Device Record Key: b2952df4-322a-47e9-94a7-42244705c353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunmed Inflation Device
• Version Model Number: 30atm, 30ml
• 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: 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	06947358563006 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-15

On-Brand Devices [Sunmed Inflation Device]

• 06947358563006: 30atm, 30ml
• 06947358568001: J Type, 28ml, 40atm/bar
• 06947358566007: J Type, 28ml, 30atm/bar