FDA.reportPublic FDA data

AUTOTRANSFUSION ACCESSORIES

Primary DI
08033178105484
Brand
AUTOTRANSFUSION ACCESSORIES
Company
SORIN GROUP ITALIA SRL
Model
BT074 COD.131
Published
2015-07-15
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

Product Codes#

Code, Name table
CodeName
DNFLIQUID CHROMATOGRAPHY, ETHOSUXIMIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DNFLiquid Chromatography, EthosuximideClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872159000DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIESShiley, Inc.1987-08-12DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033178105481PackageGS110In Commercial Distribution
38033178105485PackageGS150In Commercial Distribution
08033178105484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803317810548118033178105481
3803317810548538033178105485
08033178105484080331781054848033178105484

GMDN Terms#

Term, Definition table
TermDefinition
Blood autotransfusion system tubingA sterile length of flexible tube, typically made of synthetic polymer material(s), intended to be used in a blood autotransfusion system typically as an extension to channel blood between the bellows and the autotransfusion bag. The tubing may be used to maintain a closed-circuit during blood collection and reinfusion. 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