AccessGUDID - DEVICE: Kendall (10884527010370)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 30951514
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 30951514
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527010370
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Kendall Holter/Telemetry Kit Pouch, AA Batteries, Prep Pad, Instruction Booklet, 5 Electrodes

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:	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?
17460	Neonatal electrocardiographic electrode	A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, electrocardiograph

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
No Device Sizes

Device Record Status

Public Device Record Key: 63e2add0-f6e0-4880-89f0-e267876ae832
Public Version Date: June 23, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016