FDA.reportPublic FDA data

Mapcath stylet

Primary DI
10815149025268
Brand
Mapcath stylet
Company
CORPAK MEDSYSTEMS, INC.
Model
60-2011
Catalog number
60-2011
Device description
stylet for use with Navigator
Published
2016-08-04
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
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815149025265PackageGS110Not in Commercial Distribution
10815149025268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081514902526520815149025265
1081514902526810815149025268

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter stylet magnet detectorAn electrically-powered device designed to rapidly detect and confirm the location and orientation of the tip of a compatible, peripherally-inserted central catheter (PICC) or central venous catheter (CVC) stylet containing one or more small, specially-oriented magnets encapsulated at the distal end. It provides rapid feedback to healthcare personnel on the positioning of the catheter/stylet during initial placement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge1.4French
Device Size Text, specify0
Length106Centimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)403-3400questions@corpak.com

Regulatory Flags#

DUNS number
147530323
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815149021147CORGRIP Tube Retention System25-00825-0082016-08-04
10815149021154CORGRIP Tube Retention System25-01025-0102016-08-04
10815149021161CORGRIP Tube Retention System25-01225-0122016-08-04
10815149025442CORGRIP Tube Retention System25-01425-0142017-02-27
10815149025459CORGRIP Tube Retention System25-01625-0162017-02-27
10815149025466CORGRIP Tube Retention System25-01825-0182017-02-27
10815149021734CORFLO Y Extension Set40-100740-10072016-07-28
10815149022861CORFLO cuBBy Decompression Set56-011256-01122016-06-24
10815149022878CORFLO cuBBy Right Angle Feeding Set56-901256-90122016-06-24
10815149022885CORFLO cuBBy Right Angle Feeding Set56-902456-90242016-06-24
10815149024445CORFLO cuBBy35-901235-90122016-08-04
10815149024452CORFLO cuBBy35-902435-90242016-08-04
10815149024469Enteral Y Extension Set20-100720-10072016-08-04
10815149024711CORFLO AIV Enteral Feeding Extension Set20-1030AIV20-1030AIV2016-08-04
10815149024728CORFLO AIV Enteral Feeding Tube Extension Set20-1060AIV20-1060AIV2016-08-04
10815149024735CORFLO AIV Enteral Feeding Extension Set20-1060AIV-S20-1060AIV-S2016-08-04
10815149025275Mapcath stylet60-201860-20182016-08-04
20815149021144CORGRIP Tube Retention System25-00825-0082016-08-04
20815149021151CORGRIP Tube Retention System25-01025-0102016-08-04
20815149021168CORGRIP Tube Retention System25-01225-0122016-08-04

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Primary DI, Brand, Company table
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00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
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