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Flexima™ APDL

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Flexima™ APDL FDA UDI
Generic Name
Pleural catheter FDA UDI
Device Name
Drainage Catheter System FDA UDI
Model / Reference
M001271240 FDA UDI
Description
Drainage Catheter System FDA UDI

Identifiers

Primary DI / UDI-DI
08714729323044 FDA UDI
FDA Product Code
FFA FDA UDI
GMDN Term
Pleural catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Biliary drainNephrostomy catheterPleural catheterMediastinal drainage catheter, non-antimicrobial

Flexima™ APDL by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mediastinal drainage catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 95698ffa-5d4e-4da1-9e3d-f0c980782180 34 fields · synced May 30, 2026