AccessGUDID - DEVICE: CBL 020,PLP,.060 DIN,3LEAD,YOKE10FT,AHA (00840828125277)

GUDID

Device Identifier (DI) Information

Brand Name: CBL 020,PLP,.060 DIN,3LEAD,YOKE10FT,AHA
Version or Model: CBT-03GA-10CS-0021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5633
Company Name: CURBELL MEDICAL PRODUCTS, INC.

Primary DI Number: 00840828125277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796452311 *Terms of Use

Device Description: CBL 020,PLP,.060 DIN,3LEAD,YOKE10FT,AHA

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60635	Electrocardiographic electrode connector	A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patientÃ¢â‚¬â„¢s skin, with a socket at the other end for a plug on the lead. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081762	000

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: f2dc1981-e6e6-42cb-89ae-0c28c52b1263
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016