FDA.reportPublic FDA data

Rashkind

Primary DI
00613994760258
Brand
Rashkind
Company
MEDTRONIC, INC.
Model
007158
Device description
CATHETER 007158 WVN 5267S 5.5 50ST RSHDL
Published
2016-07-24
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
DXFCATHETER, SEPTOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994760258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994760258006139947602586139947602580613994760258

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
Catheter Gauge5.5French
Length50Centimeter
Lumen/Inner Diameter0.356Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store catheters in a cool, dry area.

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
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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