FDA.reportPublic FDA data

Holter Prep Kit

Primary DI
00857175006111
Brand
Holter Prep Kit
Company
VECTRACOR INC
Model
701900-00
Device description
Holter prep kitEach prep kit contains:1 razor1 alcohol pad1 AA battery1 skin scrubby1 page of 5 wet gel electrodes1 patient diary
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJWShave Prep Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJWShave Prep KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857175006111PrimaryGS10
10857175006118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857175006111008571750061118571750061110857175006111
1085717500611810857175006118

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording support kitA collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828416359
Device count
25
Premarket exempt
true
Kit
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857175006029VectraplexECG System3.4.22016-09-26
00857175006166Office Medic6.02017-01-23
10857175006071Plastic Mouthpieces (100)Z-5000-26082016-09-26
008571750060673L Calibration Syringe5000-19175000-19172023-06-07
00857175006173Universal SmartECGAHAZ-7000-05002023-06-07
00857175006043Universal ECGZ-7000-0301Z-7000-03012016-09-24
00857175006012Vectraplex CMSV1007052016-09-26
00857175006050Orbit SpirometerZ-7000-0101Z-7000-01012016-09-24
10857175006132Wet Gel Monitoring ElectrodesV1003002016-09-26
40857175006096Adhesive Solid Gel Electrodes (pack of 100)Z-5000-19202016-09-26
10857175006088Nose Clips724050-002016-09-26
20857175006085Nose Clips7242005-002017-02-03

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