FDA.reportPublic FDA data

SJM CONFIRM™

Primary DI
05414734502696
Brand
SJM CONFIRM™
Company
ST. JUDE MEDICAL, INC.
Model
DM2100A
Catalog number
DM2100A
Device description
External Patient Activator
Published
2017-04-10
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
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
K081365000
K101968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081365000SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATORSt Jude Medical2008-08-15MXC
K101968000SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100ASt Jude Medical2010-09-15MXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734502696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734502696054147345026965414734502696

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cardiac monitor programmer/transmitter/alarmA hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. It may be used in the home or healthcare facility.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature-4 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
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067033307Amplatzer™ Talisman™9-PFO-18189-PFO-18182021-09-29
05415067033314Amplatzer™ Talisman™9-PFO-25189-PFO-25182021-09-29
05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16

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
05414734502573SJM CONFIRM™ST. JUDE MEDICAL, INC.MXC2017-02-03
05414734502597SJM CONFIRM™ST. JUDE MEDICAL, INC.MXC2017-02-03