Organ Care System 1426

GUDID B00925733

Extracorporeal fluid flow probe Extracorporeal fluid flow probe

Primary Device ID	B00925733
NIH Device Record Key	21bcfac5-600b-48fa-a900-5cd031fe3a1a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Organ Care System
Version Model Number	1426
Catalog Number	1426
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	true
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	B00925731 [Primary]
HIBCC	B00925733 [Package] Contains: B00925731 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