AccessGUDID - DEVICE: XI.D-RL™ (04260451444013)

GUDID

Device Identifier (DI) Information

Brand Name: XI.D-RL™
Version or Model: XI.D-RL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: XI.D-RL
Company Name: Oscor Inc.

Primary DI Number: 04260451444013
Issuing Agency: GS1
Commercial Distribution End Date: December 03, 2020
Device Count: 5
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Disposable Extension Cable

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?
47143	Electrical-only medical device connection cable, single-use	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070926	000

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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 250 Centimeter

Device Record Status

Public Device Record Key: 9b204bca-af35-4ac2-8c69-8afcd1bf566e
Public Version Date: December 03, 2020
Public Version Number: 4
DI Record Publish Date: November 26, 2017