MCS+

GUDID 30812747013851

MCS+ (RBC), LIST NO 08150-220-E

HAEMONETICS CORPORATION

Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system
Primary Device ID30812747013851
NIH Device Record Key2e7bd371-af1d-4827-bab2-d733f4e6c86f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMCS+
Version Model Number08150-220-E
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
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130812747013851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKTSeparator, automated, blood cell, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-06

On-Brand Devices [MCS+]

30812747013875MCS+ (RBC), LIST NO 08150-110-E
30812747013851MCS+ (RBC), LIST NO 08150-220-E

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