FDA.reportPublic FDA data

Map-iT

Primary DI
00818083016272
Brand
Map-iT
Company
ACCESS POINT TECHNOLOGIES, INC.
Model
903702
Catalog number
903702
Device description
STR, 4 electrode, MPD-CS-S, 2mm electrode spacing
Published
2018-11-05
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
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818083016272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818083016272008180830162728180830162720818083016272

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-tip electrodeAn electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signals from the electrode can help the operator determine the presence of left-to-right heart shunt. The electrical conductor may also be used to characterize the electrical activity of the heart. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length110Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128599565
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818087022873MAGiC Sweep1810011810012026-05-15
00818087022880MAGiC Sweep1810021810022026-05-15
00818087022897MAGiC Sweep1810031810032026-05-15
00818087023054MAGiC Sweep1810191810192026-05-15
00818087023061MAGiC Sweep1810201810202026-05-15
00818087023085MAGiC Sweep1810221810222026-05-15
00818083014001Map-iT9033079033072019-06-25
00818083015909Map-iT9036029036022019-06-25
00818083015947Map-iT9036069036062019-06-25
00818083015954Map-iT9036079036072019-06-25
00818083015961Map-iT9036089036082019-06-25
00818083015978Map-iT9036099036092019-06-25
00818083015985Map-iT9036109036102019-06-25
00818083016005Map-iT9036129036122019-06-25
00818083016036Map-iT9036159036152019-06-25
00818083016050Map-iT9036179036172019-06-25
00818083016067Map-iT9036189036182019-06-25
00818083016074Map-iT9036199036192019-06-25
00818083016081Map-iT9036209036202019-06-25
00818083016258Map-iT9037009037002019-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818087022873MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022880MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022897MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
05414734202701Livewire™ST. JUDE MEDICAL, INC.DRF2023-10-31
00763000445720NAMEDTRONIC, INC.DRF2023-03-18
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10801902198409ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198393ARROWTELEFLEX INCORPORATEDDRF2022-05-11
10801902004533ARROWTELEFLEX INCORPORATEDDRF2018-10-25
20801902004301ARROWTELEFLEX INCORPORATEDDRF2018-10-25
00643169778184NAMEDTRONIC, INC.DRF2016-11-04