Diagnostic X-ray Unit

GUDID 08800040900085

Poskom Co., Ltd.

Diagnostic x-ray system generator, portable

• Primary Device ID: 08800040900085
• NIH Device Record Key: f30885eb-52a9-4e6f-a475-5c447c349390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostic X-ray Unit
• Version Model Number: PXM-40BT PLUS
• Company DUNS: 688458491
• Company Name: Poskom 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: true
• Expiration Date: false
• 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	08800040900085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032628

FDA Product Code

• IZL: System, X-Ray, Mobile

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: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [Diagnostic X-ray Unit]

• 08800040900009: PXM-20BT PLUS
• 08800040900085: PXM-40BT PLUS
• 08800040900078: PXM-20HF PLUS