FDA.reportPublic FDA data

Penumbra System

Primary DI
00815948020962
Brand
Penumbra System
Company
PENUMBRA, INC.
Model
5MAXJET7KIT-B
Device description
5MAXJET7KIT-B
Published
2019-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NRYCatheter, Thrombus Retriever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948020962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948020962008159480209628159480209620815948020962

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
191077671
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169722213Indigo SystemLITNGFXT100H1-ELITNGFXT100H12026-03-10
00810169722220Indigo SystemLITNGFHT115H1-ELITNGFXT115H12026-03-10
00810169722237Indigo SystemLITNGFHT100H1-ELITNGFHT100H12026-03-10
00810169722244Indigo SystemLITNGFHT80H1-ELITNGFHT80H12026-03-10
00810169722039swiftMATCH Coil, Extra Soft400SWXSFT101-A400SWXSFT1012026-01-26
00810169722046swiftMATCH Coil, Extra Soft400SWXSFT102-A400SWXSFT1022026-01-26
00810169722053swiftMATCH Coil, Extra Soft400SWXSFT103-A400SWXSFT1032026-01-26
00810169722060swiftMATCH Coil, Extra Soft400SWXSFT105-A400SWXSFT1052026-01-26
00810169722077swiftMATCH Coil, Extra Soft400SWXSFT202-A400SWXSFT2022026-01-26
00810169722084swiftMATCH Coil, Extra Soft400SWXSFT204-A400SWXSFT2042026-01-26
00810169722091swiftMATCH Coil, Extra Soft400SWXSFT206-A400SWXSFT2062026-01-26
00810169722107swiftMATCH Coil, Extra Soft400SWXSFT304-A400SWXSFT3042026-01-26
00810169722114swiftMATCH Coil, Extra Soft400SWXSFT306-A400SWXSFT3062026-01-26
00810169722121swiftMATCH Coil, Extra Soft400SWXSFT308-A400SWXSFT3082026-01-26
00810169722138swiftMATCH Coil, Extra Soft400SWXSFT406-A400SWXSFT4062026-01-26
00810169722145swiftMATCH Coil, Extra Soft400SWXSFT408-A400SWXSFT4082026-01-26
00810169722152swiftMATCH Coil, Extra Soft400SWXSFT410-A400SWXSFT4102026-01-26
00810169722169swiftMATCH Coil, Soft400SWSFT306-A400SWSFT3062026-01-26
00810169722176swiftMATCH Coil, Soft400SWSFT406-A400SWSFT4062026-01-26
00810169722183swiftMATCH Coil, Soft400SWSFT410-A400SWSFT4102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290015107341Tigertriever 25 Revascularization DeviceRAPID MEDICAL LTDNRY2026-03-16
00763000950750Riptide™ Aspiration PumpMicro Therapeutics, Inc.NRY2026-03-09
05391530910231Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
05391530910248Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
00763000974091Riptide™Micro Therapeutics, Inc.NRY2025-12-13
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
07290015107402Tigertriever 17 Ultra Revascularization DeviceRAPID MEDICAL LTDNRY2025-11-17
10886704086437CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086451CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086475CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086499CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086536CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086550CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086598CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086611CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704088073CEREGLIDECerenovus, Inc.NRY2025-09-26
05391539370241Millipede70 Aspiration CatheterPERFUZE LIMITEDNRY2025-09-08
00840303713524Raptor Aspiration CatheterBALT USA LLCNRY2025-08-18
00840303713623Raptor Aspiration CatheterBALT USA LLCNRY2025-08-18
00850014025236APRO 55 Swift CatheterAlembic, LLCNRY2025-06-30
00850014025274APRO 55 Swift CatheterAlembic, LLCNRY2025-06-30
00812212030757Zoom 7X CatheterIMPERATIVE CARE, INC.NRY2025-06-09
00840303709541Raptor Aspiration CatheterBALT USA LLCNRY2025-06-09
00840303709558Raptor Aspiration CatheterBALT USA LLCNRY2025-06-09
00840303709565Raptor Aspiration CatheterBALT USA LLCNRY2025-06-09
00840303709572Raptor Aspiration CatheterBALT USA LLCNRY2025-06-09
00840303709589Raptor Aspiration CatheterBALT USA LLCNRY2025-06-09
00840303709596Raptor Aspiration CatheterBALT USA LLCNRY2025-06-09