FDA.reportPublic FDA data

WorkMate Claris™

Primary DI
05415067018076
Brand
WorkMate Claris™
Company
ST. JUDE MEDICAL, INC.
Model
H701807
Catalog number
H701807
Device description
System Printer
Published
2018-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, diagnostic, programmable
JOQGenerator, pulse, pacemaker, external programmable (for electrophysiological studies only)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092913000
K210392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092913000EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04Ep Medsystems2009-10-16JOQ
K210392000WorkMate Claris SystemAbbott2021-03-11DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067018076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067018076054150670180765415067018076

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology stimulation systemAn assembly of devices programmed to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It typically includes electrodes/leads applied to the heart and an external pulse generator (EPG). It may be used in asynchronous or synchronous mode, to deliver stimuli of variable strength, and for pacing in a wide range of cycle lengths (typically from 150 to 1500 ms). It is used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and to assess sinus node function.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Serial number
true
Manufacturing date on label
true

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