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
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28