Device
The OCS™ Heart Leukocyte Depleting Filter is a sterile filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system.
Manufacturer
TRANSMEDICS, INC.
TRANSMEDICS, INC.
Model: 1466
Catalog: 1466
DI: B00962623
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
The OCS™ Heart Leukocyte Depleting Filter is a sterile filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
45443eb5-2253-4351-b6ae-ecaa059af4db
Distribution Status:
In Commercial Distribution
DUNS Number:
084445043
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Cardboard Box
Item #1 - Device ID:
B00962635
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
B00962623
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
B00962623
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 62837
Name: Donor-organ preservation/transport perfusion initiation/termination set
Definition:
A collection of sterile devices intended to be used for the initiation and/or termination of perfusion of an organ in an donor-organ preservation/transport system. It includes tubing, tube clamps and may in addition include bags, connectors/adaptors, and filters. This is a single-use device.
FDA Product Codes
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line