AVEA 16606

GUDID 70846446001275

Neonatal/Pediatric Airway Adapter/ Single Patient Use

Carefusion Corporation

Carbon dioxide cuvette, single-use Carbon dioxide cuvette, single-use

• Primary Device ID: 70846446001275
• NIH Device Record Key: b9aa0d50-a737-4657-8966-17d8d3ebfb6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVEA
• Version Model Number: 16606
• Catalog Number: 16606
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• Device Count: 10
• 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: 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: 800.231.2466
• Email: support.smcvent.us@carefusion.
• Phone: 800.231.2466
• Email: support.smcvent.us@carefusion.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846446001273 [Unit of Use]
GS1	70846446001275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103211

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-01

On-Brand Devices [AVEA]

• 70846446060395: ESOPHAGEAL PRESSURE MONITORING TUBE SET, 8FR ADULT, BX 10
• 70846446001275: Neonatal/Pediatric Airway Adapter/ Single Patient Use
• 20846446001256: AVEA DISP FILT/WTR-TRP, BOX OF 12
• 10846446001174: PATIENT BREATING CIRCUIT "48"
• 10846446001143: PATIENT BREATING CIRCUIT "72"
• 10846446015966: CONN ASSY,PROX,SMART,10 PACK
• 10846446015973: HOSE ASSY, HELIOX, 15 FT, FEM/FEM