AccessGUDID - DEVICE: Cardio Clear (00814907020319)

GUDID

Device Identifier (DI) Information

Brand Name: Cardio Clear
Version or Model: LOCZ500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LOCZ500
Company Name: CARDIO-MEDICAL PRODUCTS, INC.

Primary DI Number: 00814907020319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029286150 *Terms of Use

Device Description: RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out

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):	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?
44771	External defibrillation electrode, adult, single-use	An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. 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 [?]
K103159	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
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Humidity: between -4 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80728a6a-c9a6-4fff-ac47-c6398c5ad46d
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: July 28, 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
10814907020316	10	00814907020319		In Commercial Distribution	Box

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: 9735869500
Email: info@cardiomedicalproducts.com

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