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Tidi

FDA UDI

Class II (US FDA UDI)

by Tidi Products, Llc

Identity

Trade Name
TIDI FDA UDI
Generic Name
Urological fluid funnel FDA UDI
Device Name
Urology Drain Bag Kit Includes: Urology Drain Bag with under buttocks flap / (1) 24" x 20" Footswitch Cover, (1) 36" x 20" Footswitch Cover, and (1) Hand Control Cover FDA UDI
Model / Reference
5416 FDA UDI
Description
Urology Drain Bag Kit Includes: Urology Drain Bag with under buttocks flap / (1) 24" x 20" Footswitch Cover, (1) 36" x 20" Footswitch Cover, and (1) Hand Control Cover FDA UDI

Identifiers

Catalog Number
5416 FDA UDI
Primary DI / UDI-DI
00618125140084 FDA UDI
FDA Product Code
PUI FDA UDI
GMDN Term
Urological fluid funnel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Urological fluid funnel

Tidi by Tidi Products, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urological fluid funnel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tidi Products, Llc

Sources (1)

  • FDA UDI 4e462983-be8a-4b20-aef7-a4a05e4977f9 34 fields · synced May 30, 2026