FDA.reportPublic FDA data

MyCareLink Smart™

Primary DI
00643169569744
Brand
MyCareLink Smart™
Company
MEDTRONIC, INC.
Model
25000
Device description
MON 25000 MYCARELINK SMART US
Published
2015-07-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMHCONTAINER, SPECIMEN, STERILE
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003328

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003328SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169569744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169569744006431695697446431695697440643169569744

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator reader, home-useAn external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. 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. This is a home-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846024767NABB11A61R102026-10-26
00763000923617USB Flash Drive1560-2026-10-25
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479177638BIOexpressBIOTRONIK SE & Co. KGOSR2026-10-20
20197344225894MEDLINEMEDLINE INDUSTRIES, INC.FMH2026-10-16
04035479194406SW HMSC 3.68BIOTRONIK SE & Co. KGOSR2026-10-09
B619A90000708Kubbie Nodes & Shaves TrayKubtecFMH2026-10-09
04035479190705NEO 2601.UBIOTRONIK SE & Co. KGOSR2026-09-21
04035479190712PSW 2601.UBIOTRONIK SE & Co. KGOSR2026-09-21
00763000862336MyCareLink™MEDTRONIC, INC.OSR2026-07-26
10192253051575PrecisionCardinal Health 200, LLCFMH2026-07-09
09555240406361Cell Culture Sampler Wide Cap 2mLITL ASIA PACIFIC SDN. BHD.FMH2026-06-23
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KGOSR2024-12-18
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29