Organ Care System 1423

GUDID B00954003

Gas/fluid regulator gasket Gas/fluid regulator gasket

Primary Device ID	B00954003
NIH Device Record Key	3c72e528-5ec1-44a9-8ffe-fc43e7d29957
Commercial Distribution Status	In Commercial Distribution
Brand Name	Organ Care System
Version Model Number	1423
Catalog Number	1423
Company DUNS	084445043
Company Name	TRANSMEDICS, 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	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

Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal

Device Issuing Agency	Device ID
HIBCC	B00925681 [Primary]
HIBCC	B00954003 [Package] Contains: B00925681 Package: Cardboard Box [1 Units] In Commercial Distribution

QBA	Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Steralize Prior To Use	false
Device Is Sterile	false

B00953985	OCS Data Card
B00950841	OCS Battery
B00939301	OCS Wireless Monitor, Universal
B00925733	Pump Flow Probe
B00954003	OCS Regulator Yoke Gasket
B00954033	OCS Power Cord, North America
B00925711	OCS Mobile Base
B00912501	OCS Battery
B00953975	OCS Data Card