InH2®

GUDID 16948538362034

RESmart® Integrated Heated Humidifierfor BPAP 25A

BMC Medical Co., Ltd.

Heated respiratory humidifier

• Primary Device ID: 16948538362034
• NIH Device Record Key: e8387306-f4dd-4c88-9b9c-986cbaa62191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InH2®
• Version Model Number: BMC-50
• 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	06948538362037 [Primary]
GS1	16948538362034 [Package]; Contains: 06948538362037; Package: [4 Units]; In Commercial Distribution

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 [InH2®]

• 16948538362034: RESmart® Integrated Heated Humidifierfor BPAP 25A
• 16948538362027: RESmart® Integrated Heated Humidifier for Auto CPAP
• 16948538362010: RESmart® Integrated Heated Humidifier for CPAP