FDA.reportPublic FDA data

Interlink

Primary DI
00382903034055
Brand
Interlink
Company
BECTON, DICKINSON AND COMPANY
Model
303405
Catalog number
303405
Device description
10ml Syringe Luer Lock Tip with Vial Access Cannula
Published
2016-09-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924439000BECTON DICKINSON INTERLINK VIAL ACCESS CANNULABd Becton Dickinson Vacutainer Systems Preanalytic1993-02-12FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903034056PackageGS1100In Commercial Distribution
50382903034050PackageGS14In Commercial Distribution
00382903034055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290303405630382903034056
5038290303405050382903034050
00382903034055003829030340553829030340550382903034055

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, non-filtering/non-ventedA slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433customer_support@bd.com

Regulatory Flags#

DUNS number
124987988
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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

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