AccessGUDID - DEVICE: Richmar (00850030915368)

GUDID

Device Identifier (DI) Information

Brand Name: Richmar
Version or Model: RM-ZZAI375B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: South Dakota Partners Inc.

Primary DI Number: 00850030915368
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080639793 *Terms of Use

Device Description: BodyMed Butterfly Ionto Electrode, Bag of 12

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):	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?
46304	Drug-delivery iontophoresis system electrode, active	A dedicated, active, electrical conductor that is a component of an iontophoresis system for transcutaneous drug delivery of a localized medication (e.g., corticosteroids or local anaesthetics). It is typically a layered pad that is attached to the skin surface of the patient at the target site, and connected to the current generator with a lead wire. An applied electric field causes the ionic-solution medication to transport from a reservoir within the pad for patient exposure. It comes in a variety of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGJ	Device, Iontophoresis, Other Uses

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba790e39-c6cb-44bb-b3b8-7dc99658f4ee
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: August 02, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850030915365	2	00850030915368	2024-08-19	Not in Commercial Distribution	Inner Pack
20850030915362	12	00850030915368	2024-08-19	Not in Commercial Distribution	Case