FDA.reportPublic FDA data

Z-6™

Primary DI
04046955718047
Brand
Z-6™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
611050
Catalog number
611050
Device description
Z695 Atrio Balloon Catheter 9.5mm
Published
2021-09-04
Public version status
Update
Distribution status
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
DXFCATHETER, SEPTOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211910000Z-6 Atrioseptostomy CatheterNuMED, Inc.2021-07-19DXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955718047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955718047040469557180474046955718047

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac septostomy catheter, balloonA flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature20 Degrees Celsius22 Degrees Celsius

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309823Micro-Access Elite®6133416133412016-08-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858769006487SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006500SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006524SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006531SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006548SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006555SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006488SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006494SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006501SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006517SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006525SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006532SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006549SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006556SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00850057445404HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445411HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445428HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445435HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445442HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445459HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445466HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445473HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445480HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445497HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445503HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445510HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445275HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445282HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445299HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445305HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01