HAEMONETICS SMARTSUCTION HARMONY

GUDID 30812747016968

SMARTSUCTION HARMONY

HAEMONETICS CORPORATION

General-purpose suction system, line-powered General-purpose suction system, line-powered General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric General-purpose surgical suction system, electric
Primary Device ID30812747016968
NIH Device Record Keyd475c689-43d6-4520-9864-c4273a985a1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS SMARTSUCTION HARMONY
Version Model NumberHAR-E-115-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
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
GS130812747016968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

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 Date2015-09-24

Devices Manufactured by HAEMONETICS CORPORATION

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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

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