AccessGUDID - DEVICE: R2 (00653405058123)

GUDID

Device Identifier (DI) Information

Brand Name: R2
Version or Model: 3111-1720
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3111-1720
Company Name: Conmed Corporation

Primary DI Number: 00653405058123
Issuing Agency: GS1
Commercial Distribution End Date: October 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: PEDIATRIC R2 MULTIFUNCTION ELECTRODES: ZOLL CONNECTOR

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):	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?
45806	Multifunction cardiac electrode	An electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s), defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDD	Dc-defibrillator, low-energy, (including paddles)

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
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Less than or equal to 100J/25kg

Device Record Status

Public Device Record Key: 1784aa06-6372-49ac-91b0-dbe12c93e544
Public Version Date: April 04, 2025
Public Version Number: 4
DI Record Publish Date: October 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

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