VMWS-1

GUDID 00195278713759

Galaxy 2.0 Wall Stand

Hangwei GE Medical Systems Co., Ltd.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00195278713759
• NIH Device Record Key: 617c216c-f823-43dd-a5ec-dc8785e5c609
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: VMWS-1
• Catalog Number: VMWS-1
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(999)999-9999
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278713759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231892

FDA Product Code

• KPR: System, x-ray, stationary

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: 2023-09-26
• Device Publish Date: 2023-09-18

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