Rashkind

Primary DI
00613994760272
Brand
Rashkind
Company
MEDTRONIC, INC.
Model
007161
Device description
CATHETER 007161 WVN 5268S 4 50 ST RASHSL
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
00613994760272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994760272006139947602726139947602720613994760272

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 Gauge4French
Length50Centimeter
Lumen/Inner Diameter0.457Millimeter

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

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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

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