FDA.reportPublic FDA data

Cardio Clear

Primary DI
00814907020128
Brand
Cardio Clear
Company
CARDIO-MEDICAL PRODUCTS, INC.
Model
PH304
Catalog number
PH304
Device description
Radiotranslucent Pediatric Defibrillation Electrodes, Philips Barrel Connector
Published
2015-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K103651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103651000CARDIOMEDCardio Medical Products, Inc.2011-10-04LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814907020125PackageGS110In Commercial Distribution
00814907020128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081490702012510814907020125
00814907020128008149070201288149070201280814907020128

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillation electrode, paediatric, single-useAn electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-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) 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.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
9735869500info@cardiomedicalproducts.com

Regulatory Flags#

DUNS number
029286150
Device count
1
Lot or batch
true
Expiration date on label
true

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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