ProCell Surgical Sponge-Blood Recovery Unit SBRU-01

GUDID B890SBRU011

ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of cell- salvage/intra-operative autotransfusion (IAT). ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard cell-salvage equipment which must process the blood retrieved from ProCell™ prior to re-infusion into the patient. Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing.

Procell Surgical (us) Inc.

Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Blood-processing autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container
Primary Device IDB890SBRU011
NIH Device Record Key5fb6f232-aeaa-4632-b99c-57f19c68a8d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameProCell Surgical Sponge-Blood Recovery Unit
Version Model NumberSBRU-01
Catalog NumberSBRU-01
Company DUNS117681877
Company NameProcell Surgical (us) Inc.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com
Phone617-849-7900
Emailcustomerservice@procellsi.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB890SBRU011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACApparatus, Autotransfusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-09
Device Publish Date2020-12-01

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