BROSELOW™ BP4035

GUDID 50190752148534

CHILD BLOOD PRESSURE CUFF

VYAIRE MEDICAL, INC.

First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable First aid kit, non-medicated, reusable

• Primary Device ID: 50190752148534
• NIH Device Record Key: 768d50d8-47d8-4fb9-8fff-0f8faafe3837
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BROSELOW™
• Version Model Number: BP4035
• Catalog Number: BP4035
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752148536 [Primary]
GS1	50190752148534 [Package]; Contains: 10190752148536; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080854

FDA Product Code

• DXQ: blood pressure cuff

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: 2021-07-28
• Device Publish Date: 2021-07-20

On-Brand Devices [BROSELOW™]

• 10190752160262: ALS REPLACEMENT HARDWARE
• 50190752158038: INTUBATION MODULES
• 50190752158014: INTUBATION MODULES
• 50190752157994: INTUBATION MODULES
• 50190752157871: INTUBATION MODULES
• 50190752157857: INTUBATION MODULES
• 50190752148534: CHILD BLOOD PRESSURE CUFF