FDA.reportPublic FDA data

Confida™

Primary DI
00763000233815
Brand
Confida™
Company
MEDTRONIC, INC.
Model
CES122230
Device description
SHEATH CES122230 CONFIDA US 1YSL
Published
2020-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181817000transGlideXT Expandable IntroducerTransaortic Medical, Inc.2019-03-26DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000233815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000233815007630002338157630002338150763000233815

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store in a cool, dry place.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821329000676OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000683OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000690OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000706OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000720OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000737OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000744OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000751OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000768OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000775OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000782OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000799OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000805OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000812OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000829OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000843OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000850OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000867OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000874OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000881OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000898OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000904OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000911OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000928OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000935OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000942OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000966OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000973OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000980OptiSeal™Greatbatch LtdDYB2019-08-15
00821329000997OptiSeal™Greatbatch LtdDYB2019-08-15