AccessGUDID - DEVICE: SEALED CALL CORD,8-PIN DIN,JERON OM,10F (00840828141154)

GUDID

Device Identifier (DI) Information

Brand Name: SEALED CALL CORD,8-PIN DIN,JERON OM,10F
Version or Model: 6826+
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3158
Company Name: CURBELL MEDICAL PRODUCTS, INC.

Primary DI Number: 00840828141154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796452311 *Terms of Use

Device Description: SEALED CALL CORD,8-PIN DIN,JERON OM,10F

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):	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?
62167	Fixed call button	A battery-powered electronic switch intended to initiate an alert signal for help when manually activated by a user in response to a need of assistance (e.g., general care, low insulin levels). It typically consists of a bedside, wall-affixed, push-button or pull-cord, wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., central server, phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that assistance is needed. It is intended to be used in the home and healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILQ	System, Communication, Powered

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: b0d33a1b-83ad-4193-9cdd-5a628de7e447
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016