FDA.reportPublic FDA data

XTRA

Primary DI
04033817752219
Brand
XTRA
Company
LivaNova Deutschland GmbH
Model
100-120V
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CACAPPARATUS, AUTOTRANSFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112245000
K131553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112245000XTRASorin Group Italia S.R.L.2011-09-06CAC
K131553000XTRASorin Group Deutschland GmbH2014-03-21CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04033817752219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04033817752219040338177522194033817752219

GMDN Terms#

Term, Definition table
TermDefinition
Red blood cell-recovery autotransfusion systemAn assembly of devices designed to collect and process blood lost by a patient to obtain red blood cells for subsequent reinfusion into the same patient (i.e., autotransfusion). It typically includes a disposable suction system to collect blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., a centrifuge) to separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate microfilters, and a reinfusion bag that stores the red blood cells in saline. The system is used mainly during surgical procedures to minimize allogeneic blood use, but may be used postoperatively and in emergency or intensive care units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343225272
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04033817904137DeviceHOLDER WITH MAST-CLAMP LONG2026-01-22
04033817904144DeviceCOCKPITARM - VARIABLE HEIGHT2026-01-22
04033817753070XVAC100-120V2015-10-20
04033817900696Electronic Gas Blender10 l/min2015-10-16
04033817900702Electronic Gas Blender5 l/min2015-10-20
04033817900719Electronic Gas Blender2 l/min2015-10-14
04033817901693Virtual Kit NumberS5 LUFTBLASENÜBWERWACHUNG APC2024-07-23
04033817900474S5 Mast Roller PumpMRP 1502015-10-14
04033817900481S5 Mast Roller PumpMRP 852015-10-14
04033817900726B-Care5Sensor Module (venous)2015-10-16
04033817900818S5 Mast Roller PumpControl Panel for 1 MRP2015-10-20
04033817901075B-Care5Venous Sensor (complete)2015-10-20
04033817901150InterfaceModule DDD2015-10-20
04033817902423AccessoriesBubble Sensor 3/16“ x 1/16”2023-03-21
04033817902430AccessoriesBubble Sensor 1/4“ x 1/16“2023-03-21
04033817902447AccessoriesBubble Sensor 3/8“ x 3/32“2023-03-21
04033817902454AccessoriesBubble Sensor 1/2“ x 3/32“2023-03-21
04033817902461AccessoriesFlow Sensor 3/16“ x 1/16”2023-03-21
04033817902478AccessoriesFlow Sensor 1/4“ x 1/16“2023-03-21
04033817902485AccessoriesFlow Sensor 3/8“ x 3/32“2023-03-21

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
08033178113700XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113717XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113724XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLCAC2024-12-20
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