AccessGUDID - DEVICE: Sustainable Technologies (10192253065848)

GUDID

Device Identifier (DI) Information

Brand Name: Sustainable Technologies
Version or Model: 33134R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 33134R-
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10192253065848
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Kendall DL 6 Leads Nihon Kohden Direct Connect System Reprocessed - Single-patient-use

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:	Yes
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?
61812	Electrocardiographic lead set, reprocessed	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a previously used single-use device that has been processed for an additional single-use patient application.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Feet

Device Record Status

Public Device Record Key: 293ea229-9159-4931-8a07-39f92ee47642
Public Version Date: February 28, 2025
Public Version Number: 3
DI Record Publish Date: June 03, 2024