FDA.reportPublic FDA data

Map-iT

Primary DI
00818083016357
Brand
Map-iT
Company
ACCESS POINT TECHNOLOGIES, INC.
Model
903710
Catalog number
903710
Device description
STR, 4 electrode, MPD-CS-L, 2mm electrode spacing
Published
2018-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00818083016357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818083016357008180830163578180830163570818083016357

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
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
true
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
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
00818083016265Map-iT9037019037012019-06-25
00818083016296Map-iT9037049037042019-06-25
00818083016302Map-iT9037059037052019-06-25
00818083016319Map-iT9037069037062019-06-25
00818083016326Map-iT9037079037072019-06-25
00818083016685Map-iT9037329037322019-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00763000719272NAMEDTRONIC, INC.DRF2024-08-22
00763000719289NAMEDTRONIC, INC.DRF2024-08-22
00763000719296NAMEDTRONIC, INC.DRF2024-08-22
00763000719302NAMEDTRONIC, INC.DRF2024-08-22
00763000443214NAMEDTRONIC, INC.DRF2024-05-18
00763000465728NAMEDTRONIC, INC.DRF2024-05-18
06952450918999EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450919002EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450919019EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942598EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942611EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942628EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450942635EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952221EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952238EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952245EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952252EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952269EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952276EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952283EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952290EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952306EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952313EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21
06952450952320EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-21