Donor Doc

GUDID 00812747010200

Donor Doc version 3.x.x

HAEMONETICS CORPORATION

Configurable electronic form web-based application software Configurable electronic form web-based application software
Primary Device ID00812747010200
NIH Device Record Key02d3151a-12ce-422a-beae-b2ca2d292ef6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDonor Doc
Version Model Number3.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100812747010200 [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 Date2018-08-27
Device Publish Date2018-07-27

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

Trademark Results [Donor Doc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DONOR DOC
DONOR DOC
77133530 3722804 Live/Registered
Global Med Technologies, Inc. DBA Wyndgate Technologies
2007-03-16

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