VELA 16532-00

GUDID 10190752153325

VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY

VYAIRE MEDICAL, INC.

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10190752153325
• NIH Device Record Key: fd3831cd-0240-432b-83a6-df5a0c23e4a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VELA
• Version Model Number: 16532-00
• Catalog Number: 16532-00
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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	10190752153325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093094

FDA Product Code

• CBK: Ventilator, continuous, facility use

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: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [VELA]

• 10190752156272: Pediatric / Adult Airway Adapter
• 10190752154230: VELA DIAMOND PACKAGE FOR KINDRED HEALTHCARE
• 10190752154223: VELA CF COMP,DISS,GRN,O2,ENG,REFURM
• 10190752153837: KIT,OXIMETER MOUNT-VELA
• 10190752153455: VELA COMP CF,DISS,GRN O2,TYPE K,ICON OVERLAY
• 10190752153448: VELA CF COMP,NIST BLUE O2,ENG OVERLAY
• 10190752153387: VELA CF,DISS,GRN O2,TYPE K,ICON OVERLAY
• 10190752153370: VELA CF,NIST,BLUE O2,ENG OVERLAY
• 10190752153363: VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY
• 10190752153349: VELA PLUS INT CF,DISS,GRN O2,TYPE K,ICON OVERLAY
• 10190752153332: VELA CF PLUS,NIST BLUE O2,ENG OVERLAY
• 10190752153325: VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY
• 10190752153271: VELA CF COMP,DISS,GRN O2,TYPE A,ICON OVERLAY
• 10190752153158: PATIENT BREATHING CIRC, PEDIAT, VELA DIAM
• 10190752153141: PATIENT BREATHING CIRC,ADULT,VELA DIAM
• 10190752186521: VELA CF,DISS,GRN O2,TYPE K,ENG OVERLAY