FDA.reportPublic FDA data

Micro-Access Elite®

Primary DI
04046964309823
Brand
Micro-Access Elite®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
613341
Catalog number
613341
Device description
4FX12CM MEH-018X50 NT/AU GW-7CM NDL
Published
2016-08-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K043525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043525000CATHETER INTRODUCERGalt Medical Corp.2005-02-09DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964309823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964309823040469643098234046964309823

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309847Micro-Access Elite®6133426133422016-08-09
04046964309861Micro-Access Elite®6133436133432016-08-09
04046964309885Micro-Access Elite®6133446133442016-08-09
04046964309908Micro-Access Elite®6133456133452016-08-09
04046964309922Micro-Access Elite®6133466133462016-08-09
04046964309946Micro-Access Elite®6133476133472016-08-09
04046964309960Micro-Access Elite®6133486133482016-08-09
04046964309977Micro-Access Elite®6133496133492016-08-09
04046964310003Micro-Access Elite®6133506133502016-08-09
04046964310027Micro-Access Elite®6133516133512016-08-09
04046964310041Micro-Access Elite®6133526133522016-08-09
04046964310065Micro-Access Elite®6133536133532016-08-09
04046964310089Micro-Access Elite®6133546133542016-08-09
04046964310102Micro-Access Elite®6133556133552016-08-09
04046964310126Micro-Access Elite®6133566133562016-08-09
04046964310140Micro-Access Elite®6133576133572016-08-09
04046964310164Micro-Access Elite®6133586133582016-08-09
04046964310188Micro-Access Elite®6133596133592016-08-09
04046964310201Micro-Access Elite®6133606133602016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226416ARROWTELEFLEX INCORPORATEDDYB2026-08-03
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DYB2026-07-31
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193206ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196184ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19