B&B Bubbler 25312

GUDID 00850008733031

Water Seal CPAP Valve, 12 units

B&B Medical Technologies

PEEP valve, single-use

• Primary Device ID: 00850008733031
• NIH Device Record Key: d125384a-1157-4c17-8a13-25bbbee9219b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B&B Bubbler
• Version Model Number: 25312
• Catalog Number: 25312
• Company DUNS: 829743579
• Company Name: B&B Medical Technologies
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850008733031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133210

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

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: 2019-07-22
• Device Publish Date: 2019-07-12

On-Brand Devices [B&B Bubbler]

• 00850008733055: Water Seal CPAP Valve, 24 units
• 00850008733031: Water Seal CPAP Valve, 12 units