Map-iT 901541

GUDID 00818083011994

Fixed, 10 electrode, CS, 5mm electrode spacing

ACCESS POINT TECHNOLOGIES, INC.

Catheter-tip electrode
Primary Device ID00818083011994
NIH Device Record Key5132e105-628b-45d4-a9a5-f6e95c2146c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMap-iT
Version Model Number901541
Catalog Number901541
Company DUNS128599565
Company NameACCESS POINT TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Catheter Gauge6 French
Length65 Centimeter
Catheter Gauge6 French
Length65 Centimeter
Catheter Gauge6 French
Length65 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100818083011994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-20
Device Publish Date2018-10-20

On-Brand Devices [Map-iT]

00818087020541Fixed,6 electrode, MPB, 5-5-5-175-175mm electrode spacing
00818087020534Fixed, 6 electrode, MPA, 5-5-5-175-175mm electrode spacing
00818087020527Fixed, 6 electrode, MPB, 5-5-5-175-175mm electrode spacing
00818087020510Fixed, 6 electrode, MPA, 5-5-5-175-175mm electrode spacing
00818087020503STR, 4 electrode, MPD-CS-S, 5mm electrode spacing
00818087020442Fixed, 4 electrode, MPB, 2mm electrode spacing
00818087020435Fixed, 4 electrode, MPA, 2-5-2mm electrode spacing
00818087020428Fixed, 4 electrode, MPB, 5mm electrode spacing
00818087020404STR, 10 electrode, MPD-DL, 5mm electrode spacing
00818087020398Fixed Curve Duo-Decapolar Catheter with Guidewire Tip
00818087020381Fixed Curve Decapolar Catheter with Guidewire Tip
00818087020374Shrouded Quad Extension Cable, Steerable 4 pole, Black, Reusable
00818087020367Shrouded Quad Extension Cable, Red, Reusable
00818087020350Steerable Quadripolar Catheter, Multi-Purpose D Curve-D
00818087020343Steerable Quadripolar Catheter, Multi-Purpose D Curve-B
00818087020336Steerable Quadripolar Catheter, Multi-Purpose D Curve-B
00818087020329Shrouded Quad Extension Cable, Black, Reusable
00818087020312Fixed Curve Quadripolar Catheter, Multi-Purpose A Curve
00818087020305Shrouded Deca Extension Cable, Fixed 20 pole, Black, Reusable
00818087020299Shrouded Deca Extension Cable, Steerable 10 pole, Black, Reusable
00818087020282Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-H
00818087020275Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-H
00818087020268Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL
00818087020251Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL
00818087020244Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL
00818087020237Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL
00818087020220Steerable Duo-Decapolar Catheter, Multi-Purpose D Curve-DL
00818087020213Fixed Curve Duo-Decapolar Catheter with Guidewire Tip
00818087020206Fixed Curve Duo-Decapolar Catheter with Guidewire Tip
00818087020190Fixed Curve Duo-Decapolar Catheter with Guidewire Tip
00818087020183Fixed Curve Duo-Decapolar Catheter with Guidewire Tip
00818087020176Fixed Curve Duo-Decapolar Catheter with Guidewire Tip
00818087020169Fixed Curve Decapolar Catheter with Guidewire Tip
00818087020152Fixed Curve Decapolar Catheter with Guidewire Tip
00818087020145Fixed Curve Decapolar Catheter with Guidewire Tip
00818087020138Fixed Curve Decapolar Catheter with Guidewire Tip
00818087020121Fixed Curve Decapolar Catheter, Multi-Purpose A Curve
00818087020114Fixed Curve Decapolar Catheter, Multi-Purpose A Curve
00818087020107Steerable Decapolar Catheter, Multi-Purpose D Curve-SL
00818087020091Steerable Decapolar Catheter, Multi-Purpose D Curve-SL
00818087020084Steerable Decapolar Catheter, Multi-Purpose D Curve-SL
00818087020077Steerable Decapolar Catheter, Multi-Purpose D Curve-SL
00818087020060Steerable Decapolar PV Catheter, Pulmonary Vein 24
00818087020053Steerable Decapolar PV Catheter, Pulmonary Vein 21
00818087020046Steerable Decapolar PV Catheter, Pulmonary Vein 18
00818087020039Steerable Decapolar PV Catheter, Pulmonary Vein 15
00818087020022Steerable Decapolar PV Catheter, Pulmonary Vein 12
00818087020015Fixed Curve Decapolar Catheter, Multi-Purpose A Curve
00818087020008Fixed Curve Decapolar Catheter, Multi-Purpose A Curve
00818083019907Fixed, 10 electrode, S, 2-10-2mm electrode spacing

Trademark Results [Map-iT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAP-IT
MAP-IT
86674282 4895153 Live/Registered
SOUTH-TEK SYSTEMS, LLC
2015-06-25
MAP-IT
MAP-IT
85921200 4685362 Live/Registered
Access Point Technologies
2013-05-02

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