FDA.reportPublic FDA data

Cardio Clear

Primary DI
10814907020101
Brand
Cardio Clear
Company
CARDIO-MEDICAL PRODUCTS, INC.
Model
LTZ200
Catalog number
LTZ200
Device description
RadioTranslucent Defibrillation Electrodes, Zoll Connector, Leads Out
Published
2015-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103334000CARDIO MEDCardio Medical Products, Inc.2011-01-18LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814907020101PackageGS110In Commercial Distribution
00814907020104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081490702010110814907020101
00814907020104008149070201048149070201040814907020104

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode, adult, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order 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) 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9735869500info@cardiomedicalproducts.com

Regulatory Flags#

DUNS number
029286150
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814907020029Cardio ClearLTA202LTA2022015-07-28
00814907020036Cardio ClearLOCA502LOCA5022015-07-28
00814907020050Cardio ClearH104H1042015-07-28
00814907020067Cardio ClearP403P4032015-07-28
00814907020074Cardio ClearA402A4022015-07-28
00814907020081Cardio ClearTH204TH2042015-07-28
00814907020098Cardio ClearLTH204LTH2042015-07-28
00814907020104Cardio ClearLTZ200LTZ2002015-07-28
00814907020111Cardio ClearLOCH504LOCH5042015-07-28
00814907020135Cardio ClearO101O1012015-07-28
00814907020142Cardio ClearO101-SO101-S2015-07-28
00814907020159Cardio ClearO401O4012015-07-28
00814907020166Cardio ClearTO201TO2012015-07-28
00814907020173Cardio ClearLTO201LTO2012015-07-28
00814907020180Cardio ClearLOCO501LOCO5012015-07-28
00814907020203Cardio ClearP103P1032015-07-28
00814907020210Cardio ClearH404H4042015-07-28
00814907020227Cardio ClearTP203TP2032015-07-28
00814907020234Cardio ClearLTP203LTP2032015-07-28
00814907020241Cardio ClearLOCP503LOCP5032015-07-28

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Primary DI, Brand, Company table
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00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
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