Flexima™ Nasobiliary Catheter Kit

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name: Flexima™ Nasobiliary Catheter Kit FDA UDI
Generic Name: Biliary drain FDA UDI
Device Name: Nasobiliary Catheter with Jagwire™ Guidewire FDA UDI
Model / Reference: M00540640 FDA UDI
Description: Nasobiliary Catheter with Jagwire™ Guidewire FDA UDI

Identifiers

Primary DI / UDI-DI: 08714729337454 FDA UDI
FDA Product Code: FGE FDA UDI
GMDN Term: Biliary drain FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Biliary drain

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Boston Scientific

Sources (1)

FDA UDI 97c5c9d8-541a-4df6-8764-81d7f1cc6bba 34 fields · synced May 30, 2026