FDA.reportPublic FDA data

SPIROFLEX

Primary DI
00616258003887
Brand
SPIROFLEX
Company
Bayer Healthcare LLC
Model
106553-001
Catalog number
106553
Device description
SPIROFLEX CUS CATH, FG PKG
Published
2014-10-09
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
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616258003887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616258003887006162580038876162580038870616258003887

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-780-4555michael.burnside@bayer.com

Regulatory Flags#

DUNS number
079415074
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888853030517EssureESS305-R12014-09-04
10888853003051EssureESS3052014-09-04
20888853003058EssureESS305 (Kit)2014-09-04
00616258003832AVX105039-0011050392014-10-09
00616258003849XVG105042-0011050422014-10-09
00616258003856SPIROFLEX VG106608-0011066082014-10-07
00616258003894XMI105041-0011050412014-10-07
00616258003917SOLENT PROXI109676-0011096762014-10-09
00616258003924SOLENT OMNI 109681-0011096812014-10-07
00616258003955FETCH 2109400-0011094002014-10-09
00616258005089SOLENT DISTA111303-0011113032014-10-09
00616258005096DISTAFLEX111304-0011113042014-10-07
00616258005164JETWIRE011525-0010115252015-02-27
00311017405307Dr. Scholl's 16121712016-09-01
00311017405321Dr. Scholl's 16121712016-09-01
00311017405345Dr. Scholl's 16121712016-09-01
00011017576983Dr. Scholl's 16121712018-02-12
10311017405304Dr. Scholl's 16121712016-09-01
00016500574057Aleve16135382017-09-01
00325866565044Aleve 16135382016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076916008LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916015LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916022LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916039LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916046LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916053LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916060LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916077LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916084LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916091LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916107LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916114LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916121LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916855LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00885403530374Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530381Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530398Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00884450466995Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-27
00884450466988Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00884450467008Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00885403530534FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyDXE2026-08-14
00885403530404FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530411FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530428FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530442FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530466FogartyBecton, Dickinson And CompanyDXE2026-07-31