AccessGUDID - DEVICE: CARTO 3 System eco Interface Cable (10846835022056)

GUDID

Device Identifier (DI) Information

Brand Name: CARTO 3 System eco Interface Cable
Version or Model: D134402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D134402
Company Name: Biosense Webster Inc

Primary DI Number: 10846835022056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020163218 *Terms of Use

Device Description: Interface Cable

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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTD	Catheter, intracardiac mapping, high-density array

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193237	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not use if package is opened
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82161d21-2cf4-4385-9b4a-9178b412b3fb
Public Version Date: September 30, 2022
Public Version Number: 3
DI Record Publish Date: July 30, 2021