OCS Lung Donor Flush Set 2406

GUDID B00958755

OCS Lung Donor Flush Set

TRANSMEDICS, INC.

Donor-organ preservation/transport perfusion initiation/termination set

Primary Device ID	B00958755
NIH Device Record Key	090e1752-f384-46e1-9e6d-533b9216197d
Commercial Distribution Status	In Commercial Distribution
Brand Name	OCS Lung Donor Flush Set
Version Model Number	2406
Catalog Number	2406
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	true
Lot Batch	true
Serial Number	false
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	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com
Phone	9784947494
Email	xzhuang@transmedics.com

Device Dimensions

Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch
Height	4 Inch
Width	12 Inch
Length	18 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00958753 [Primary]
HIBCC	B00958755 [Package] Contains: B00958753 Package: Cardboard Box [1 Units] In Commercial Distribution

FDA Product Code

MSB	System And Accessories, Isolated Heart, Transport And Preservation

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-21
Device Publish Date	2023-06-13

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