Balloon inflation device 102001

GUDID 06971162817437

Tianck Medical Co., Ltd.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 06971162817437
• NIH Device Record Key: ca9e8c74-1422-41db-a33c-aa219b4beb4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon inflation device
• Version Model Number: GT20ML
• Catalog Number: 102001
• Company DUNS: 418642903
• Company Name: Tianck Medical 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	06971162817437 [Primary]
GS1	16971162817434 [Package]; Package: middle package [10 Units]; In Commercial Distribution
GS1	26971162817431 [Package]; Contains: 16971162817434; Package: outer package [4 Units]; In Commercial Distribution

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: 2023-02-14
• Device Publish Date: 2023-02-06

On-Brand Devices [Balloon inflation device]

• 06971162811756: Balloon inflation device
• 06971162819738: BT25ML
• 06971162819707: AT25ML
• 06971162817437: GT20ML
• 06936841201037: BT40
• 16936841201973: ATHV
• 06971162817789: GT-type balloon inflation device with a hemostasis valve.