Hisense

GUDID 06978311950601

Ultrasound Diagnostic System

Qingdao Hisense Medical Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06978311950601
• NIH Device Record Key: 0ae75a41-a26d-4da8-9068-6555ec1d38a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hisense
• Version Model Number: HD45
• Company DUNS: 509751307
• Company Name: Qingdao Hisense Medical 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	06978311950601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233439

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: 2025-10-07
• Device Publish Date: 2025-09-29

On-Brand Devices [Hisense]

• 06978311951110: Ultrasound Diagnostic System
• 06978311951103: Ultrasound Diagnostic System
• 06978311951097: Ultrasound Diagnostic System
• 06978311951080: Ultrasound Diagnostic System
• 06978311951073: Ultrasound Diagnostic System
• 06978311951066: Ultrasound Diagnostic System
• 06978311951059: Ultrasound Diagnostic System
• 06978311951042: Ultrasound Diagnostic System
• 06978311951035: Ultrasound Diagnostic System
• 06978311951028: Ultrasound Diagnostic System
• 06978311951011: Ultrasound Diagnostic System
• 06978311951004: Ultrasound Diagnostic System
• 06978311950991: Ultrasound Diagnostic System
• 06978311950984: Ultrasound Diagnostic System
• 06978311950977: Ultrasound Diagnostic System
• 06978311950960: Ultrasound Diagnostic System
• 06978311950953: Ultrasound Diagnostic System
• 06978311950946: Ultrasound Diagnostic System
• 06978311950939: Ultrasound Diagnostic System
• 06978311950922: Ultrasound Diagnostic System
• 06978311950915: Ultrasound Diagnostic System
• 06978311950908: Ultrasound Diagnostic System
• 06978311950892: Ultrasound Diagnostic System
• 06978311950885: Ultrasound Diagnostic System
• 06978311950878: Ultrasound Diagnostic System
• 06978311950861: Ultrasound Diagnostic System
• 06978311950854: Ultrasound Diagnostic System
• 06978311950847: Ultrasound Diagnostic System
• 06978311950830: Ultrasound Diagnostic System
• 06978311950823: Ultrasound Diagnostic System
• 06978311950816: Ultrasound Diagnostic System
• 06978311950809: Ultrasound Diagnostic System
• 06978311950793: Ultrasound Diagnostic System
• 06978311950786: Ultrasound Diagnostic System
• 06978311950779: Ultrasound Diagnostic System
• 06978311950762: Ultrasound Diagnostic System
• 06978311950755: Ultrasound Diagnostic System
• 06978311950748: Ultrasound Diagnostic System
• 06978311950731: Ultrasound Diagnostic System
• 06978311950724: Ultrasound Diagnostic System
• 06978311950717: Ultrasound Diagnostic System
• 06978311950700: Ultrasound Diagnostic System
• 06978311950694: Ultrasound Diagnostic System
• 06978311950687: Ultrasound Diagnostic System
• 06978311950670: Ultrasound Diagnostic System
• 06978311950663: Ultrasound Diagnostic System
• 06978311950656: Ultrasound Diagnostic System
• 06978311950649: Ultrasound Diagnostic System
• 06978311950632: Ultrasound Diagnostic System
• 06978311950625: Ultrasound Diagnostic System