Duette™

FDA UDI

Class II (US FDA UDI)

by Poiesis Medical, Llc

Identity

Trade Name: Duette™ FDA UDI
Generic Name: Indwelling urethral catheterization kit, adult FDA UDI
Device Name: 16FR Duette™ Indwelling Urinary Catheter Urine Meter Tray FDA UDI
Model / Reference: K-10016U FDA UDI
Description: 16FR Duette™ Indwelling Urinary Catheter Urine Meter Tray FDA UDI

Identifiers

Primary DI / UDI-DI: 10852732004071 FDA UDI
FDA Product Code: OHR FDA UDI
GMDN Term: Indwelling urethral catheterization kit, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral catheterization kit, adult

Duette™ by Poiesis Medical, Llc — 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: Poiesis Medical, Llc

Sources (1)

FDA UDI fd79a0f2-e8d7-415a-89e5-19c88a8d84be 36 fields · synced May 30, 2026