FDA.reportPublic FDA data

N/A

Primary DI
30382903065371
Brand
N/A
Company
BECTON, DICKINSON AND COMPANY
Model
306537
Catalog number
306537
Device description
SASH KIT 5ML FILL/10ML SYR 100U/ML HEP
Published
2016-09-16
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
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903065375PackageGS14In Commercial Distribution
30382903065371PrimaryGS10
00382903065370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290306537550382903065375
3038290306537130382903065371
00382903065370003829030653703829030653700382903065370

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter flush syringeA sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
001292192
Device count
10
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903840120BD Introsyte Autoguard3840123840122016-10-20
00382903840083BD Introsyte-N Autoguard, BD Instaflash3840083840082016-10-20
00382903840106BD Introsyte Autoguard3840103840102016-10-20
00382903840113BD Introsyte Autoguard3840113840112016-10-20
50382903840217BD Introsyte-N, BD Instaflash3840213840212016-10-20
50382903840309BD Introsyte3840303840302016-10-20
50382903840316BD Introsyte-N3840313840312016-10-20
50382903840408BD Introsyte3840403840402016-10-20
50382903840507BD Introsyte3840503840502016-10-20
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay4411264411262018-05-25
00885403523437HemoSphere AltaALTAALL1ALTAALL12026-08-06
00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
00885403523475HemoSphere AltaALTACR1ALTACR12026-08-06
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
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10801902130331ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130355ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130379ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902133004ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133028ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133042ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133066ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133080ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133233ARROWTELEFLEX INCORPORATEDFOZ2017-03-08
10801902133127ARROWTELEFLEX INCORPORATEDFOZ2017-03-07
10801902132816ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902132823ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133097ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133103ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902131529ARROWTELEFLEX INCORPORATEDFOZ2017-02-17
10801902131512ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
10801902131567ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
00801741074769Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
00801741074783Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130935ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902129359ARROWTELEFLEX INCORPORATEDFOZ2016-11-11