INT,Force Inflation Device

GUDID 26950900920015

20 ml, 30 atm, I, 500 psi OFF stopcock

Shanghai Kindly Medical Instruments 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: 26950900920015
• NIH Device Record Key: dfbdbfef-ad8f-40d2-b628-4f0eec250777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INT,Force Inflation Device
• Version Model Number: AI30
• Company DUNS: 420827639
• Company Name: Shanghai Kindly Medical Instruments 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950900920011 [Primary]
GS1	26950900920015 [Package]; Contains: 06950900920011; Package: box [5 Units]; In Commercial Distribution
GS1	46950900920019 [Package]; Contains: 06950900920011; Package: carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170027

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: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [INT,Force Inflation Device]

• 26950900920039: 20 ml, 30 atm, II, 500 psi OFF stopcock
• 26950900920015: 20 ml, 30 atm, I, 500 psi OFF stopcock