io

GUDID 16948538360108

ioTM Mini Nasal Mask

BMC Medical Co., Ltd.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 16948538360108
• NIH Device Record Key: d99c522d-d429-4e98-8216-e4700a036588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: io
• Version Model Number: Size: Medium
• 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: true
• Serial Number: false
• 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	06948538360101 [Primary]
GS1	16948538360108 [Package]; Contains: 06948538360101; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131901

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 [io]

• 16948538360115: ioTM Mini Nasal Mask
• 16948538360108: ioTM Mini Nasal Mask
• 16948538360092: ioTM Mini Nasal Mask