HAEMONETICS CELL SAVER ELITE SYSTEM

GUDID 30812747016531

CS ELITE PROCESSING KIT (125ML)

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set
Primary Device ID30812747016531
NIH Device Record Key8f472fd9-3e9c-4d15-925f-317ceb8c39d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS CELL SAVER ELITE SYSTEM
Version Model NumberCSE-P-125
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter
Total Volume10 Liter
Total Volume1000 Milliliter
Total Volume125 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110812747016537 [Primary]
GS130812747016531 [Package]
Contains: 10812747016537
Package: Carton [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-08
Device Publish Date2015-09-24

On-Brand Devices [HAEMONETICS CELL SAVER ELITE SYSTEM]

30812747016616CELL SAVER ELITE
30812747016630CS ELITE FASTPACK, 225ML, 20µ
30812747016586CS ELITE FASTPACK,225ML,150µ
30812747016579CS ELITE FASTPACK,125ML,150µ
30812747016562WASTE BAG, 10L
30812747016555SEQUESTRATION KIT
30812747016548CS ELITE PROCESSING KIT (225ML)
30812747016531CS ELITE PROCESSING KIT (125ML)
30812747016524CS ELITE PROCESSING KIT (70ML)
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