LF400

GUDID 18809802640259

Main device 1ea, OVERLAPPING LEG SLEEVE Small X-Wide(SXW401) 2ea, Single Hose 2ea [One set box]

DAESUNG MAREF CO.,LTD.

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• Primary Device ID: 18809802640259
• NIH Device Record Key: d84dcaf1-14ac-4c0f-9124-a089b1fa3926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LF400
• Version Model Number: LF40100-OSX
• 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: 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	08809802640252 [Primary]
GS1	18809802640259 [Package]; Contains: 08809802640252; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150033

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2021-12-23
• Device Publish Date: 2021-12-15

On-Brand Devices [LF400]

• 18809802640358: Main device 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 2ea, Single Hose 2ea [One
• 18809802640341: Main device 1ea, OVERLAPPING ARM SLEEVE Large(L402) 2ea, Single Hose 2ea [One set box]
• 18809802640334: Main device 1ea, OVERLAPPING ARM SLEEVE Medium(M402) 1ea, Single Hose 1ea [One set box]
• 18809802640327: Main device 1ea, OVERLAPPING HALF-LEG SLEEVE Medium Wide(MW403) 2ea, Single Hose 2ea [One set b
• 18809802640310: Main device 1ea, OVERLAPPING HALF-LEG SLEEVE Medium(M403) 2ea, Single Hose 2ea [One set box]
• 18809802640303: Main device 1ea, OVERLAPPING LEG SLEEVE Large Wide(LW401) 2ea, Single Hose 2ea [One set box]
• 18809802640297: Main device 1ea, OVERLAPPING LEG SLEEVE Large(L401) 2ea, Single Hose 2ea [One set box]
• 18809802640280: Main device 1ea, OVERLAPPING LEG SLEEVE Medium X-Wide(MXW401) 2ea, Single Hose 2ea [One set box]
• 18809802640273: Main device 1ea, OVERLAPPING LEG SLEEVE Medium Wide(MW401) 2ea, Single Hose 2ea [One set box]
• 18809802640266: Main device 1ea, OVERLAPPING LEG SLEEVE Medium(M401) 2ea, Single Hose 2ea [One set box]
• 18809802640259: Main device 1ea, OVERLAPPING LEG SLEEVE Small X-Wide(SXW401) 2ea, Single Hose 2ea [One set box]
• 18809802640242: Main device 1ea, OVERLAPPING LEG SLEEVE Small Wide(SW401) 2ea, Single Hose 2ea [One set box]
• 18809802640235: Main device 1ea, OVERLAPPING LEG SLEEVE Small(S401) 2ea, Single Hose 2ea [One set box]
• 18809315679982: Main device 1ea [One set box]
• 08809315679978: Main device 1ea
• 18809802640228: Main device 1ea, OVERLAPPING ARM CHEST 1ea, Strap 10*40 1ea, 5*40 1ea, 10*80 1ea, 5*80 1ea, Sin