FDA.reportPublic FDA data

Flexima™ APD™

Primary DI
08714729323945
Brand
Flexima™ APD™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001275060
Device description
Drainage Catheter System with Dissolving Tip
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
FFATUBE, DRAINAGE, SUPRAPUBIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFATube, Drainage, SuprapubicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729323945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729323945087147293239458714729323945

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00792293985095Uro-Kit® Reusable Latex Leg Bag System 9 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985101Uro-Kit® Reusable Latex Leg Bag System 10 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985163Uro-Kit® Reusable Latex Leg Bag System 16 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985187Uro-Kit® Reusable Latex Leg Bag System 18 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985262Uro-Kit® Reusable Latex Leg Bag System 26 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293985323Uro-Kit® Reusable Latex Leg Bag System 32 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293995100Uro-Kit® Reusable Latex Leg Bag System 10 oz.UROCARE PRODUCTS, INC.FFA2018-04-10
00792293995162Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.)UROCARE PRODUCTS, INC.FFA2018-04-09
00792293995261Uro-Kit® Reusable Latex Leg Bag System 26 oz.UROCARE PRODUCTS, INC.FFA2018-04-09
00792293995322Uro-Kit® Reusable Latex Leg Bag System 32 oz.UROCARE PRODUCTS, INC.FFA2018-04-09
00792293995445Uro-Kit® Reusable Latex Leg Bag System 44 oz.UROCARE PRODUCTS, INC.FFA2018-04-09
08714729127970Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191759Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191766Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191773Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191780Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191797Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191803Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191810Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729191827Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729271369Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729271376Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729271383Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729300670Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729300694Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323044Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323051Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323068Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323075Flexima™ APD™BOSTON SCIENTIFIC CORPORATIONFFA2016-09-24
08714729323082Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24