AccessGUDID - DEVICE: Kendall (10884521212657)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 33136RT72
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33136RT72
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521212657
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: DL Disposable Lead Set 5 Lead, Radiolucent

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?
36038	Radiolucent electrocardiographic lead	A radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Length: 6 Feet

Device Record Status

Public Device Record Key: 6755e00f-e0d6-486d-9a12-f80918030cd0
Public Version Date: February 15, 2019
Public Version Number: 5
DI Record Publish Date: September 24, 2016