FDA.reportPublic FDA data

BD Intelliport System

Primary DI
00382905168031
Brand
BD Intelliport System
Company
BECTON, DICKINSON AND COMPANY
Model
516803
Catalog number
516803
Device description
SYRINGE LABELER INK CARTRIDGE
Published
2024-06-07
Public version status
Update
Distribution status
Not 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
PHCInfusion safety management software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
PHCInfusion Safety Management SoftwareGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382905168036PackageGS14Not in Commercial Distribution
60382905168033PackageGS124Not in Commercial Distribution
00382905168031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290516803650382905168036
6038290516803360382905168033
00382905168031003829051680313829051680310382905168031

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 Temperature00

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
30382903679929BD Vacutainer® SST™ Blood Collection Tube3679923679922026-07-20
00382904440039BD BACTEC™ FXI Software4440034440032026-07-06
00382905167065BD Intelliport5167065167062020-09-30
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02

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