Saturo

FDA UDI

Class I (US FDA UDI)

by Bio Nuclear Diagnostics, Inc.

Identity

Trade Name: Saturo FDA UDI
Generic Name: Urine transfer IVD, sterile FDA UDI
Device Name: Urine Collection Container Yellow Cap ST FDA UDI
Model / Reference: URC-120Y FDA UDI
Description: Urine Collection Container Yellow Cap ST FDA UDI

Identifiers

Primary DI / UDI-DI: 00754013505471 FDA UDI
FDA Product Code: FMH FDA UDI
GMDN Term: Urine transfer IVD, sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3250 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Urine transfer IVD, sterile

Saturo by Bio Nuclear Diagnostics, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Bio Nuclear Diagnostics, Inc.

Sources (1)

FDA UDI 4b82afd5-8853-45eb-8ad0-e093cb3912ae 33 fields · synced May 30, 2026