Elution Test Vial

FDA UDI

Class II (US FDA UDI)

by Bracco Diagnostics Inc.

Identity

Trade Name: Elution Test Vial FDA UDI
Generic Name: General laboratory container, single-use FDA UDI
Device Name: Elution Test Vial for use with CardioGen-82 Infusion System FDA UDI
Model / Reference: 001730 FDA UDI
Description: Elution Test Vial for use with CardioGen-82 Infusion System FDA UDI

Identifiers

Primary DI / UDI-DI: 30815112020577 FDA UDI
FDA Product Code: FRN FDA UDI
GMDN Term: General laboratory container, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: General laboratory container, single-use

Elution Test Vial by Bracco Diagnostics Inc. — 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: Bracco Diagnostics Inc.

Sources (1)

FDA UDI aaa56eec-06d3-4cf1-a81e-6aa6855d7876 34 fields · synced Jun 8, 2026