RESmart®

GUDID 06948538365151

RESmart® BPAP System

BMC Medical Co., Ltd.

Home BPAP unit

• Primary Device ID: 06948538365151
• NIH Device Record Key: be685641-2d38-4baa-a0d4-00851ebe9d83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESmart®
• Version Model Number: 25A
• Company DUNS: 526010310
• Company Name: BMC Medical 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-863-226-6285
• Email: cpewitt@3Bproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948538365151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133769

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-10
• Device Publish Date: 2016-05-19

On-Brand Devices [RESmart®]

• 06948538365151: RESmart® BPAP System
• 06948538365144: RESmart® BPAP System with Integrated Heated Humidifier
• 06948538363096: RESmart® Auto CPAP System
• 06948538363089: RESmart® Auto CPAP System with Integrated Heated Humidifier
• 06948538363072: RESmart® CPAP System
• 06948538363065: RESmart® CPAP System with Integrated Heated Humidifier