DVT-4000S

GUDID 18809315675663

Main Device 1ea, Tubing(Single hose 1.5m) 2ea [One set box]

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 18809315675663
• NIH Device Record Key: 5122fbfa-1591-4a68-bf1d-2a40912c3f45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT-4000S
• Version Model Number: DVT421-01
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF 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: true
• 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	08809315675666 [Primary]
GS1	18809315675663 [Package]; Contains: 08809315675666; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203417

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2021-06-29
• Device Publish Date: 2021-06-21

On-Brand Devices [DVT-4000S]

• 18809315675663: Main Device 1ea, Tubing(Single hose 1.5m) 2ea [One set box]
• 08809315675314: DVT-4000S Device 1ea