HAEMONETICS CELL SAVER SYSTEMS

GUDID 30812747016098

RBC BAG W/TWIST LOCK, 1000ML

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set
Primary Device ID30812747016098
NIH Device Record Key8942c0be-58ad-4266-b22d-8fdf2e9b62d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHAEMONETICS CELL SAVER SYSTEMS
Version Model Number00245-00
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com
Phone800-537-2802
Emailpirdesk@Haemonetics.com

Device Dimensions

Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110812747016094 [Primary]
GS120812747016091 [Package]
Contains: 10812747016094
Package: Dispenser [10 Units]
In Commercial Distribution
GS130812747016098 [Package]
Contains: 20812747016091
Package: Carton [4 Units]

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 Date2017-06-27

On-Brand Devices [HAEMONETICS CELL SAVER SYSTEMS]

30812747016098RBC BAG W/TWIST LOCK, 1000ML
30812747016012WASTE BAG, 5L
30812747016005RBC BAG WITH LUER LOCK, 600ML

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