Rio II Full Face Mask

GUDID 06948538368251

Rio II Full Face Mask

BMC Medical Co., Ltd.

CPAP/BPAP face mask, reusable

• Primary Device ID: 06948538368251
• NIH Device Record Key: d4262319-33cc-4498-be19-580702db6904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rio II Full Face Mask
• Version Model Number: FPF+(All Size Kit)
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948538368251 [Primary]
GS1	16948538368258 [Package]; Package: [15 Units]; In Commercial Distribution

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2024-04-08
• Device Publish Date: 2024-03-29

On-Brand Devices [Rio II Full Face Mask]

• 16948538368289: Rio II Full Face Mask
• 16948538368272: Rio II Full Face Mask
• 16948538368265: Rio II Full Face Mask
• 06948538368251: Rio II Full Face Mask