FDA.reportPublic FDA data

XTRA

Primary DI
08033178113984
Brand
XTRA
Company
SORIN GROUP ITALIA SRL
Model
WASTE BAG X 10 L
Published
2024-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K240584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240584000XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.2024-04-29CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178113985PackageGS110In Commercial Distribution
08033178113984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317811398538033178113985
08033178113984080331781139848033178113984

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal circuit waste bagA flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device.

Regulatory Flags#

DUNS number
442126587
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178018203Venous Cardiopolmunary Bypass CannulaRDS-610342025-12-19
08033178018227Venous Cardiopolmunary Bypass CannulaRDS-610402025-12-19
08033178018234Venous Cardiopolmunary Bypass CannulaRDS-610462025-12-19
08033178018258Venous Cardiopolmunary Bypass CannulaRDS-611342025-12-19
08033178018272Venous Cardiopolmunary Bypass CannulaRDS-611402025-12-19
08033178018289Venous Cardiopolmunary Bypass CannulaRDS-611462025-12-19
08033178018296Venous Cardiopolmunary Bypass CannulaRDS-611502025-12-19
08033178018364Venous Cardiopolmunary Bypass CannulaRV-400162025-12-19
08033178018371Venous Cardiopolmunary Bypass CannulaRV-400182025-12-19
08033178018388Venous Cardiopolmunary Bypass CannulaRV-400202025-12-19
08033178018395Venous Cardiopolmunary Bypass CannulaRV-400222025-12-19
08033178018401Venous Cardiopolmunary Bypass CannulaRV-400242025-12-19
08033178018418Venous Cardiopolmunary Bypass CannulaRV-400262025-12-19
08033178018425Venous Cardiopolmunary Bypass CannulaRV-400282025-12-19
08033178018432Venous Cardiopolmunary Bypass CannulaRV-400302025-12-19
08033178018449Venous Cardiopolmunary Bypass CannulaRV-400322025-12-19
08033178018456Venous Cardiopolmunary Bypass CannulaRV-400342025-12-19
08033178018463Venous Cardiopolmunary Bypass CannulaRV-400362025-12-19
08033178018487Venous Cardiopolmunary Bypass CannulaRV-405362025-12-19
08033178018524Venous Cardiopolmunary Bypass CannulaRV-410182025-12-19

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
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
08033178114073XTRASORIN GROUP ITALIA SRLCAC2024-12-20