3100A/B HFOV 766897

GUDID 10190752148840

Stationary electric high-frequency ventilator

Primary Device ID	10190752148840
NIH Device Record Key	5b0d1a30-eeb0-4ce7-af55-db1277e32ab2
Commercial Distribution Status	In Commercial Distribution
Brand Name	3100A/B HFOV
Version Model Number	766897
Catalog Number	766897
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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

Device Issuing Agency	Device ID
GS1	10190752148840 [Primary]

LSZ	VENTILATOR, HIGH FREQUENCY

Steralize Prior To Use	false
Device Is Sterile	false

10190752187818 - iFlow	2024-11-13 iFlow 200 S Adult/Pediatric Proximal Flow Sensor
50190752187823 - iFlow	2024-11-13 iFlow 40 S Neonatal/Infant Proximal Flow Sensor
50190752200805 - LTV	2024-11-13 Patient Circuit W/O PEEP, 15mm, SPU, Single Heated Wire, F&P
50190752200829 - LTV	2024-11-13 Patient Circuit W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P
10190752201019 - 3100 HFOV	2024-11-13 Tube Set, Filtered Patient Circuit
10190752201118 - LTV	2024-11-13 Patient Circuit Ventilator Adapter
50190752201536 - LTV	2024-11-13 Patient Circuit, W/ PEEP, 15mm, SPU
50190752200751 - LTV	2024-08-21 Patient Circuit W/O PEEP, 22mm, SPU, Single Heated Wire, F&P