AccessGUDID - DEVICE: Devon (20884521215013)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31404851
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 31404851
Company Name: Cardinal Health, Inc.

Primary DI Number: 20884521215013
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 7382-0T02 Birthday Kit

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	Yes
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?
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLS	Labor and Delivery Kit

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: No;

Device Record Status

Public Device Record Key: 922a9d94-7974-4c85-bdf3-c008c65ea30a
Public Version Date: February 11, 2022
Public Version Number: 10
DI Record Publish Date: May 20, 2017