RL-500

GUDID 08809315679770

Device 1ea, CPM 1ea, GLOVE 1ea, Hose set 1ea

DAESUNG MAREF CO.,LTD.

Hand/wrist continuous passive motion exerciser

• Primary Device ID: 08809315679770
• NIH Device Record Key: 38a99ea9-2c3e-44a4-981d-da5b3f802fad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RL-500
• Version Model Number: RL5020E
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	08809315679770 [Primary]

FDA Product Code

• BXB: Exerciser, Powered

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: 2021-06-22
• Device Publish Date: 2021-06-14

On-Brand Devices [RL-500]

• 08809315679787: GLOVE 1EA
• 18809315679814: Hose 1ea, Com cable 1ea (1 set box)
• 18809315679807: Detection Hub 1ea (One poly bag)
• 18809315679791: PEN 1EA (One poly bag)
• 08809315679770: Device 1ea, CPM 1ea, GLOVE 1ea, Hose set 1ea
• 08809315679763: RL-500 device + CPM