Map-iT

Basic Information

• Brand Name: Map-iT
• Primary DI: 00818083017002
• Version / Model: 903804
• Catalog Number: 903804
• Company Name: ACCESS POINT TECHNOLOGIES, INC.
• Labeler DUNS: 128599565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-07
• Public Version: 2
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 248ccd3b-8b16-4333-8b8f-fdcab5d20a59

Device Description

STR, 4 electrode, MPD-CS-M, 2-5-2mm electrode spacing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11434	Intracardiac catheter-tip electrode	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818083017002	GS1

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French
Length	110	Centimeter