AccessGUDID - DEVICE: Kendall (10884527021499)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 33509
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 33509
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527021499
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 25
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: DL 17 Pin Adapter,5 Lead

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):	No
Over the Counter (OTC):	Yes
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?
31683	Electrocardiographic lead switching adaptor	A switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 30a71939-2cbf-42f4-b1a3-897b651bc51f
Public Version Date: October 02, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016