HAEMONETICS CELL SAVER ELITE+ SYSTEM

GUDID 30812747014100

HAEMONETICS CORPORATION

Autotransfusion system blood collection/processing pump
Primary Device ID30812747014100
NIH Device Record Key8bd6f155-a956-4720-af19-eff69d12ed5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS CELL SAVER ELITE+ SYSTEM
Version Model NumberCSE-EX-US
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS130812747014100 [Primary]

FDA Product Code

CACApparatus, autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-20
Device Publish Date2025-06-12

On-Brand Devices [HAEMONETICS CELL SAVER ELITE+ SYSTEM]

30812747016364CELL SAVER ELITE+

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.