FDA.reportPublic FDA data

SJM CONFIRM™

Primary DI
05414734502597
Brand
SJM CONFIRM™
Company
ST. JUDE MEDICAL, INC.
Model
DM2100
Catalog number
DM2100
Device description
Implantable Cardiac Monitor
Published
2017-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MXCRECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101968000
K122090000
K122161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101968000SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100ASt Jude Medical2010-09-15MXC
K122090000SJM CONFIRM IMPLANTABLE CARDIAC MONITORSt. Jude Medical, Cardiac Rhythm Management Divisi2012-11-15MXC
K122161000SJM CONFIRMSt Jude Medical2012-11-28MXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734502597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734502597054147345025975414734502597

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac monitorA hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit
Special Storage Condition, Specify00Store the device in a clean area.
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067047311Merlin.net™ST. JUDE MEDICAL, INC.MXC2023-06-16
05415067047793Assert-IQ™ST. JUDE MEDICAL, INC.MXC2023-06-13
05415067047809Assert-IQ™ST. JUDE MEDICAL, INC.MXC2023-06-13
05415067047816Assert-IQ™ST. JUDE MEDICAL, INC.MXC2023-06-13
05415067040046Jot Dx™ST. JUDE MEDICAL, INC.MXC2021-07-09
05415067034304Confirm Rx™ST. JUDE MEDICAL, INC.MXC2020-12-09
05415067027320Confirm Rx™ST. JUDE MEDICAL, INC.MXC2017-11-13
05415067027399myMerlin™ST. JUDE MEDICAL, INC.MXC2017-11-13
05415067027405myMerlin™ST. JUDE MEDICAL, INC.MXC2017-11-13
05414734502696SJM CONFIRM™ST. JUDE MEDICAL, INC.MXC2017-04-10
05414734502573SJM CONFIRM™ST. JUDE MEDICAL, INC.MXC2017-02-03