ReFlow Mini Flusher A022-1

GUDID 00860024001847

Anuncia Medical, Inc.

Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 00860024001847
• NIH Device Record Key: a9b037e4-b542-4b84-b668-ca843da85edf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReFlow Mini Flusher
• Version Model Number: A022-1
• Catalog Number: A022-1
• Company DUNS: 081149501
• Company Name: Anuncia Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com
• Phone: (978) 942-5600
• Email: info@anunciamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860024001847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223603

FDA Product Code

• JXG: Shunt, Central Nervous System And Components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30