HAEMONETICS ORTHOPAT SYSTEM

GUDID 30812747017149

ORTHOPAT INTEGRATED SET

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set

Primary Device ID	30812747017149
NIH Device Record Key	1be464f5-37b2-4979-a8a2-0afd796ff8ca
Commercial Distribution Status	In Commercial Distribution
Brand Name	HAEMONETICS ORTHOPAT SYSTEM
Version Model Number	1150H-00
Company DUNS	057827420
Company Name	HAEMONETICS CORPORATION
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com
Phone	+1(800)-537-2802
Email	pirdesk@Haemonetics.com

Device Dimensions

Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter
Total Volume	400 Milliliter
Total Volume	3 Liter
Total Volume	2 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747017145 [Primary]
GS1	30812747017149 [Package] Contains: 10812747017145 Package: Carton [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K962475

FDA Product Code

CAC	Apparatus, Autotransfusion

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-01-08
Device Publish Date	2015-09-24

On-Brand Devices [HAEMONETICS ORTHOPAT SYSTEM]

10812747017374	QUICKCONNECT RESERVOIR
30812747017361	OPAT QUICKCONNECT PROCESS SET
30812747017149	ORTHOPAT INTEGRATED SET
30812747017118	ORTHOPAT EXTENDED POST-OP LINE
30812747017040	ORTHOPAT POST-OP LINE