FDA.reportPublic FDA data

CardioCard Holter

Primary DI
G466CUSBHOLT0
Brand
CardioCard Holter
Company
NASIFF ASSOCIATES INC
Model
CUSBHOLTER
Catalog number
CC-HOLTER
Device description
Cardio Card Holter, Ambulatory, Mobile System.
Published
2023-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960544000CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEMNasiff Assoc., Inc.1996-08-07DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G466CUSBHOLT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3156762346nasales@nasiff.com

Regulatory Flags#

DUNS number
612902684
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G466CUSBNIBP0CardioCard NIBPCUSBNIBP2023-04-04
G466CUSB0CardioCardCUSB2023-03-17

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Primary DI, Brand, Company table
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