FDA.reportPublic FDA data

BLOOD COLLECTION RESERVOIR

Primary DI
38033178109759
Brand
BLOOD COLLECTION RESERVOIR
Company
SORIN GROUP ITALIA SRL
Model
30 µm Filter
Published
2015-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CACAPPARATUS, AUTOTRANSFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178109759PackageGS16In Commercial Distribution
08033178109758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317810975938033178109759
08033178109758080331781097588033178109758

GMDN Terms#

Term, Definition table
TermDefinition
Red blood cell-recovery 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

Regulatory Flags#

DUNS number
442126587
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
38033178102934DHF02 HEMOCONCENTRATOR2015-07-15
38033178102941DHF06 HEMOCONCENTRATOR2015-07-15
38033178233638SH14 - HEMOCONCENTRATOR2015-07-15
38033178019621Aortic Root cannulaAR-131142026-03-06
38033178019638Aortic Root cannulaAR-191142026-03-06
38033178019645Vessel CannulaVC-120002026-03-06
38033178019652Vessel CannulaVC-120102026-03-06
38033178019669Vessel CannulaVC-120202026-03-06
38033178019676Vessel CannulaVC-220102026-03-06
38033178017191Cardioplegia CannulaAR-110122026-02-11
38033178017207Cardioplegia CannulaAR-110142026-02-11
38033178017214Cardioplegia CannulaAR-110162026-02-11
38033178017221Cardioplegia CannulaAR-110182026-02-11
38033178017238Cardioplegia CannulaAR-111122026-02-11
38033178017245Cardioplegia CannulaAR-111142026-02-11
38033178017252Cardioplegia CannulaAR-111162026-02-11
38033178017269Cardioplegia CannulaAR-170122026-02-11
38033178017276Cardioplegia CannulaAR-170142026-02-11
38033178017313Cardioplegia CannulaAX-303212026-02-11
38033178018075Coronary Sinus CannulaRCM-141152026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34026704912200PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
34026704912217PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
34026704911791PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
34026704911807PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
30812747014100HAEMONETICS CELL SAVER ELITE+ SYSTEMHAEMONETICS CORPORATIONCAC2025-06-12
44026704911866PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
18033178113707XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113725XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113756XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113763XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113923XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113930XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113947XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113954XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113985XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178113992XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114005XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114036XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114043XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114050XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114074XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114111XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114128XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114142XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114333XTRASORIN GROUP ITALIA SRLCAC2024-12-20
38033178114739XTRASORIN GROUP ITALIA SRLCAC2024-12-20
34026704933076PLEUR-EVACTELEFLEX INCORPORATEDCAC2024-11-18
00860009303416Aventus Thrombectomy System - Clot Management SystemInquis Medical, Inc.CAC2024-07-23
00810123710546FlowSaverINARI MEDICAL INCCAC2024-05-29
24026704921830PLEUR-EVACTELEFLEX INCORPORATEDCAC2024-02-07