FDA.reportPublic FDA data

XVAC

Primary DI
04033817753070
Brand
XVAC
Company
LivaNova Deutschland GmbH
Model
100-120V
Published
2015-10-20
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
K110782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110782000XVACSorin Group Italia S.R.L.2011-04-07CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04033817753070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04033817753070040338177530704033817753070

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, pneumaticAn assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.

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
04033817900696Electronic Gas Blender10 l/min2015-10-16
04033817900702Electronic Gas Blender5 l/min2015-10-20
04033817900719Electronic Gas Blender2 l/min2015-10-14
04033817752219XTRA100-120V2015-10-16
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