HAEMONETICS CELL SAVER SYSTEM

GUDID 30812747016043

ASPIRATION/ANTICOAGULATION SET

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set
Primary Device ID30812747016043
NIH Device Record Keyc31b8f85-29a0-4cc6-94e5-ea0c1739bf0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS CELL SAVER SYSTEM
Version Model Number00208-00
Company DUNS057827420
Company NameHAEMONETICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110812747016049 [Primary]
GS120812747016046 [Package]
Contains: 10812747016049
Package: Dispenser [5 Units]
In Commercial Distribution
GS130812747016043 [Package]
Contains: 20812747016046
Package: Carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-08
Device Publish Date2017-08-16

On-Brand Devices [HAEMONETICS CELL SAVER SYSTEM]

30812747016340CELL SAVER STEP DOWN ADAPTER
30812747016074Y SET WITH EXTENSION LINE
10812747016063RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (
30812747016043ASPIRATION/ANTICOAGULATION SET
30812747016036RESERVOIR,HARDSHELL,150 µ_ Note: Additional packaging DI: 20812747016039, Unit Packaging, conta
10812747016025Y CONNECTOR WITH CHECK VALVE

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