FDA.reportPublic FDA data

NA

Primary DI
00763000181185
Brand
NA
Company
MEDTRONIC, INC.
Model
2292
Device description
CABLE 2292 MDT GLBL
Published
2023-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC
KRGProgrammer, pacemaker
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1
KRGProgrammer, PacemakerCardiovascular3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890003437

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890003437SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071Medtronic, Inc.1989-08-24NVZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000181185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000181185007630001811857630001811850763000181185

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479190705NEO 2601.UBIOTRONIK SE & Co. KGOSR2026-09-21
04035479190712PSW 2601.UBIOTRONIK SE & Co. KGOSR2026-09-21
07333350030384Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350102111Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350354831Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350472917Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350589110Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350929640Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350094850Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
07333350874889Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
00850087488808CeeportCEEPORT INC.FQM2026-08-26
00850087488815CeeportCEEPORT INC.FQM2026-08-26
00850087488822CeeportCEEPORT INC.FQM2026-08-26
00850087488839CeeportCEEPORT INC.FQM2026-08-26
00050428124505CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFQM2026-08-14
00763000862336MyCareLink™MEDTRONIC, INC.OSR2026-07-26
00850088144024CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144031CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144048CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144055CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144062CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144079CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144086CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144666CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144673CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144680CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10