FDA.reportPublic FDA data

N/A

Primary DI
50382903033664
Brand
N/A
Company
BECTON, DICKINSON AND COMPANY
Model
303366
Catalog number
303366
Device description
CANNULA INTERLINK SYRINGE
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920422000B-D INTERLINK SYRINGE CANNULABd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903033664PackageGS110In Commercial Distribution
30382903033660PrimaryGS10
00382903033669Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290303366450382903033664
3038290303366030382903033660
00382903033669003829030336693829030336690382903033669

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter adaptorA connecting device, usually a small part, intended to be used to join an applied catheter to an external device(s) used in the intravenous administration of fluids to a patient. This device will typically be used when the devices to be connected are from different manufacturers and are non-compatible, enabling them to mate together. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
124987988
Device count
100
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403523512HemoSphere AltaHEMA70CC2HEMA70CC22026-09-18
00885403523536HemoSphere AltaHEMAPSC200HEMAPSC2002026-09-18
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKBB64EKBB2026-09-18
00885403533146TruWave Reusable Cable64EKGE164EKGE12026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKGE264EKGE22026-09-18
00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
00885403533665TruWave Reusable CablePX15S162PX15S1622026-09-18
00885403533764Smart Pressure ControllerPC1QPC1Q2026-09-18
00885403533771Smart Pressure Controller Accessory KitPC1QAKPC1QAK2026-09-18
00885403543282TruWave Reusable CablePX12S162PX12S1622026-09-18
00885403543299TruWavePX17S162PX17S1622026-09-18
00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
00885403543435TruWavePX2D162PX2D1622026-09-18
00885403543459TruWavePX11T162PX11T1622026-09-18
00885403543466TruWavePX7D162PX7D1622026-09-18

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