VisionAir 3D Stent 0010-0126

GUDID 00860011822608

The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.

VisionAir Solutions, LLC

Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable Polymeric tracheal/bronchial stent, non-bioabsorbable

Primary Device ID	00860011822608
NIH Device Record Key	37e39507-6052-4773-8154-a97e8a9f7f7e
Commercial Distribution Status	In Commercial Distribution
Brand Name	VisionAir 3D Stent
Version Model Number	1
Catalog Number	0010-0126
Company DUNS	081278969
Company Name	VisionAir Solutions, LLC
Device Count	1
DM Exempt	true
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	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
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	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com
Phone	2168005905
Email	info@visionairsolutions.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811813020525 [Previous]
GS1	00860011822608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213969

FDA Product Code

NWA	Prosthesis, Tracheal, Preformed/Molded