AccessGUDID - DEVICE: Map-iT (00818087020305)

GUDID

Device Identifier (DI) Information

Brand Name: Map-iT
Version or Model: 901957
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901957
Company Name: ACCESS POINT TECHNOLOGIES, INC.

Primary DI Number: 00818087020305
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 128599565 *Terms of Use

Device Description: Shrouded Deca Extension Cable, Fixed 20 pole, Black, Reusable

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 [?]
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: ce8e9249-d50a-4069-a0ac-808ee5a5cd28
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 11, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 763-432-9004
Email: aptepcustomerservice@apt-inc.us

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