ProCell Surgical Sponge-Blood Recovery Unit

Primary DI
B890SBRU011
Brand
ProCell Surgical Sponge-Blood Recovery Unit
Company
Procell Surgical (us) Inc.
Model
SBRU-01
Catalog number
SBRU-01
Device description
ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary stepin the process of cell- salvage/intra-operative autotransfusion (IAT).ProCell™ functions as a blood collection device only and does not filter or otherwiseprocess the blood recovered. As an accessory to IAT, it is used in conjunction withstandard 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 disposableProCell™ can be used repeatedly during a surgical case and provides an alternative toother sponge-blood recovery methods including hand-wringing.
Published
2020-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CACApparatus, Autotransfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193361000ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc.2020-06-01CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B890SBRU011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood-processing autotransfusion system containerA simple blood collection container used for the collection of autologous blood from a patient undergoing major surgery. The blood is then cleansed in a line-powered (AC-powered) blood-processing autotransfusion system (commonly known as a cell saver) before the red cells are reinfused into the patient, or stored for later use. It is made of disposable plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617-849-7900customerservice@procellsi.com

Regulatory Flags#

DUNS number
117681877
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937230PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937308PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937315PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704912206PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704912213PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704911797PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911803PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911865PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
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08033178113717XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113724XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLCAC2024-12-20
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08033178113939XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113946XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113953XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113984XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLCAC2024-12-20