AccessGUDID - DEVICE: Map-iT (00818083019921)

GUDID

Device Identifier (DI) Information

Brand Name: Map-iT
Version or Model: 901959
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901959
Company Name: ACCESS POINT TECHNOLOGIES, INC.

Primary DI Number: 00818083019921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 128599565 *Terms of Use

Device Description: Mapping Catheter Extension Cable: deca fixed, duo-deca fixed, duo-deca steerable, 14-pin female

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47483	Electrocardiographic lead/catheter adaptor	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	Cable, Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 210 Centimeter

Device Record Status

Public Device Record Key: 9bff6edb-18fd-45c7-a0ae-d47e515ebbd1
Public Version Date: July 03, 2019
Public Version Number: 1
DI Record Publish Date: June 25, 2019