DVT-2600

GUDID 18809315675427

Main device 1ea, Tubing(Single hose 2.3m) 2ea [One set]

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 18809315675427
• NIH Device Record Key: f7f84476-b9dd-4cdd-b26f-f557ea40bcd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT-2600
• Version Model Number: DS0102
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809315675420 [Primary]
GS1	18809315675427 [Package]; Contains: 08809315675420; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203016

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-2600]

• 18809315675434: Main device 1ea, Tubing(Single hose 3m) 2ea, [One set]
• 18809315675427: Main device 1ea, Tubing(Single hose 2.3m) 2ea [One set]
• 08809315675307: DVT-2600 Device 1ea