CDCS (Cross Donation Check System)

GUDID 00812747010064

CDCS version 1.x.x

HAEMONETICS CORPORATION

Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software
Primary Device ID00812747010064
NIH Device Record Keyc76c7890-473a-4340-b9f9-98119d7a0ea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDCS (Cross Donation Check System)
Version Model Number1.x.x
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 Batchtrue
Serial Numberfalse
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
GS100812747010064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MMHBlood Establishment Computer Software and Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

Devices Manufactured by HAEMONETICS CORPORATION

30812747013516 - MCS+ (LN8150) RBC APHERESIS2023-10-19 2 UNIT RED CELL SET W/RC2H FIL
30812747015008 - HAEMONETICS ACP 215 SYSTEM2023-10-19 RBC GLYCEROLIZATION SET
30812747015015 - HAEMONETICS ACP 215 SYSTEM2023-10-19 RBC DE-GLYCEROL./CELL WASH SET
30812747015022 - HAEMONETICS ACP 215 SYSTEM2023-10-19 RBC DE-GLYCEROL. SET 325ML BMB
10812747018043 - TEG HEMOSTASIS SYSTEM2023-10-10 CALCIUM CHLORIDE, 0.2M, 5 ML
30812747019334 - Haemonetics® NexSys PCS® System2023-07-07 0625Q-00 Plasma Bowl
30812747012861 - MCS 90002023-02-15
30812747011710 - Haemonetics® PCS®2, NexSys PCS® & MCS®+ Systems2022-11-03 PLS Bag w/Vac Sampling

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.