AIR RELAX UAM-8100

GUDID 38809040523691

4 CHAMBER DEVICE

Maxstar Industrial Co.,Ltd.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 38809040523691
• NIH Device Record Key: b3ee306e-fe5a-407b-ba15-add3e3787bf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR RELAX
• Version Model Number: UAM-8100
• Catalog Number: UAM-8100
• Company DUNS: 687844027
• Company Name: Maxstar Industrial 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: true
• 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

Customer Support Contacts

• Phone: +82319893543
• Email: overseas@maxstar.co.kr
• Phone: +82319893543
• Email: overseas@maxstar.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	38809040523691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130385

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-14

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