FDA.reportPublic FDA data

Flexima™ APD™

Primary DI
08714729271376
Brand
Flexima™ APD™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001271260
Device description
Drainage Catheter System
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
08714729271376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729271376087147292713768714729271376

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainA flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). 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
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
08714729323099Flexima™ APDLBOSTON SCIENTIFIC CORPORATIONFFA2016-09-24