FDA.reportPublic FDA data

Map-iT

Primary DI
00818083019921
Brand
Map-iT
Company
ACCESS POINT TECHNOLOGIES, INC.
Model
901959
Catalog number
901959
Device description
Mapping Catheter Extension Cable: deca fixed, duo-deca fixed, duo-deca steerable, 14-pin female
Published
2019-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818083019921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818083019921008180830199218180830199210818083019921

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead/catheter adaptorA small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length210Centimeter

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Hydrogen Peroxide""]"
Ethylene Oxide;Hydrogen Peroxide

Regulatory Flags#

DUNS number
128599565
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
07613327688771N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-10-08
B631ADSP2PH51SureleadAuthentic MedicalIKD2026-10-07
B631TCDR2GE510C1SureleadAuthentic MedicalIKD2026-10-07
B631TCDRN52MRT510C1SureleadAuthentic MedicalIKD2026-10-07
B631TCMXAS4C1SureleadAuthentic MedicalIKD2026-10-07
B631TCZLX2PH53M1SureleadAuthentic MedicalIKD2026-10-07
B631TCSP2PH123M1SureleadAuthentic MedicalIKD2026-10-01
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14