Vyntus ECG V-375610-13

GUDID 34250892906066

Electrocardiography telemetric monitoring system transmitter

Primary Device ID	34250892906066
NIH Device Record Key	45d2bf9a-c3e3-4361-9ca1-31e984183627
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vyntus ECG
Version Model Number	V-375610-13
Catalog Number	V-375610-13
Company DUNS	329769991
Company Name	Vyaire Medical GmbH
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Issuing Agency	Device ID
GS1	34250892906066 [Primary]

BZC	Calculator, Pulmonary Function Data

Steralize Prior To Use	false
Device Is Sterile	false