FDA.reportPublic FDA data

BD Intelliport System

Primary DI
50382905168012
Brand
BD Intelliport System
Company
BECTON, DICKINSON AND COMPANY
Model
516801
Catalog number
516801
Device description
SYRINGE LABELER LUER LABEL CASSETTE
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382905168012PackageGS14In Commercial Distribution
60382905168019PackageGS124In Commercial Distribution
00382905168017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290516801250382905168012
6038290516801960382905168019
00382905168017003829051680173829051680170382905168017

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous injection automated detection/documentation system processor/transmitterA noninvasive electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically interface with a system sensor to: 1) provide power to, and extract IV bolus injection volume data from, the sensor; and 2) process and wirelessly transmit data to a computer as part of automatic detection/documentation of patient anaesthesia dosing. It is typically designed as a sensor base with a processor and wireless transmitter; it might include a barcode reader (for encoded syringe scanning) and an internal clock (for time of dose data collection). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
1
DM exempt
false
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
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
10885403533822BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-23
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17