Hisense

GUDID 06933741401123

Ultrasound Diagnostic System

Qingdao Hisense Medical Equipment Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 06933741401123
• NIH Device Record Key: 245b4fb0-d16a-4da2-9514-0782570871b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hisense
• Version Model Number: HD61 Exp
• Company DUNS: 544312126
• Company Name: Qingdao Hisense Medical Equipment Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06933741401123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213862

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2022-07-13
• Device Publish Date: 2022-07-05

On-Brand Devices [Hisense]

• 06933741401338: Ultrasound Diagnostic System
• 06933741401321: Ultrasound Diagnostic System
• 06933741401314: Ultrasound Diagnostic System
• 06933741401307: Ultrasound Diagnostic System
• 06933741401291: Ultrasound Diagnostic System
• 06933741401284: Ultrasound Diagnostic System
• 06933741401277: Ultrasound Diagnostic System
• 06933741401260: Ultrasound Diagnostic System
• 06933741401253: Ultrasound Diagnostic System
• 06933741401246: Ultrasound Diagnostic System
• 06933741401239: Ultrasound Diagnostic System
• 06933741401222: Ultrasound Diagnostic System
• 06933741401215: Ultrasound Diagnostic System
• 06933741401208: Ultrasound Diagnostic System
• 06933741401192: Ultrasound Diagnostic System
• 06933741401185: Ultrasound Diagnostic System
• 06933741401178: Ultrasound Diagnostic System
• 06933741401161: Ultrasound Diagnostic System
• 06933741401154: Ultrasound Diagnostic System
• 06933741401147: Ultrasound Diagnostic System
• 06933741401130: Ultrasound Diagnostic System
• 06933741401123: Ultrasound Diagnostic System
• 06933741401116: Ultrasound Diagnostic System
• 06933741401109: Ultrasound Diagnostic System
• 06933741401093: Ultrasound Diagnostic System
• 06933741401086: Ultrasound Diagnostic System
• 06933741401079: Ultrasound Diagnostic System
• 06933741401062: Ultrasound Diagnostic System
• 06933741401055: Ultrasound Diagnostic System
• 06933741401048: Ultrasound Diagnostic System
• 06933741401031: Ultrasound Diagnostic System
• 06933741401024: Ultrasound Diagnostic System
• 06933741401017: Ultrasound Diagnostic System
• 06933741401000: Ultrasound Diagnostic System
• 06933741401406: Ultrasound Diagnostic System
• 06933741401390: Ultrasound Diagnostic System
• 06933741401383: Ultrasound Diagnostic System
• 06933741401376: Ultrasound Diagnostic System
• 06933741401369: Ultrasound Diagnostic System
• 06933741401352: Ultrasound Diagnostic System
• 06933741401345: Ultrasound Diagnostic System
• 06933741401475: Ultrasound Diagnostic System
• 06933741401468: Ultrasound Diagnostic System
• 06933741401451: Ultrasound Diagnostic System
• 06933741401444: Ultrasound Diagnostic System
• 06933741401437: Ultrasound Diagnostic System
• 06933741401420: Ultrasound Diagnostic System
• 06933741401413: Ultrasound Diagnostic System
• 06933741401628: Ultrasound transducer
• 06933741401611: Ultrasound transducer