VITEK® 2 0, 45% Sodium Chloride Diluent

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: VITEK® 2 0,45% Sodium Chloride Diluent FDA UDI
Generic Name: Saline suspension medium/diluent IVD FDA UDI
Device Name: VITEK 2.0 0.45% SALINE INDIVIDUAL BAG FDA UDI
Model / Reference: VITEK® 2 0,45% Sodium Chloride Diluent FDA UDI
Description: VITEK 2.0 0.45% SALINE INDIVIDUAL BAG FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026556969 FDA UDI
FDA Product Code: LON FDA UDI
LTW FDA UDI
GMDN Term: Saline suspension medium/diluent IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1645 FDA UDI
866.1640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

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

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

Category: Saline suspension medium/diluent IVD

VITEK® 2 0, 45% Sodium Chloride Diluent by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Saline suspension medium/diluent IVD.

Saline Solution (0.85%) — Biomed Diagnostics, Inc. · Class I
KOLPLAST — Kolplast CI SA · Class I
SALINE SOLUTION — BIOMERIEUX , INC. · Class II
SALINE SOLUTION — BIOMERIEUX , INC. · Class II

Cleared under the same submission

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: Biomerieux , Inc.

Sources (1)

FDA UDI b7ed2a94-42b0-4896-bd8b-cf5f06caa97f 35 fields · synced May 30, 2026