AccessGUDID - DEVICE: Kendall (20192253017714)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 31177721
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 31177721
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20192253017714
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: KENDALL 1210H Defibrillation Electrode, Nonsterile, Product Code 31177721

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":	Yes
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?
11130	Electrode conductive skin pad, single-use	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated External Defibrillators (Non-Wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: Protect from Light
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e791e5a-b2fa-4c04-884a-a8c77b2c9e09
Public Version Date: June 23, 2023
Public Version Number: 1
DI Record Publish Date: June 15, 2023