Osmette Iii

FDA UDI

Class I (US FDA UDI)

by Precision Systems, Inc.

Identity

Trade Name: OSMETTE III FDA UDI
Generic Name: Osmometric analyser IVD FDA UDI
Device Name: Precision Systems OSMETTE III osmometer, 110 V FDA UDI
Model / Reference: 5010 FDA UDI
Description: Precision Systems OSMETTE III osmometer, 110 V FDA UDI

Identifiers

Catalog Number: 5010 FDA UDI
Primary DI / UDI-DI: 00850041049823 FDA UDI
FDA Product Code: JJM FDA UDI
GMDN Term: Osmometric analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Osmometric analyser IVD

Osmette Iii by Precision Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osmometric analyser IVD.

ScoutPro Osmolarity System — Tearlab Corporation · Class I
A20 Advanced Automated Osmometer — Advanced Instruments, LLC · Class I
FreezePoint® Freezing Point Osmometer — ELITECHGROUP INC. · Class I
FreezePoint® Freezing Point Osmometer — ELITECHGROUP INC. · Class I
FreezePoint® Freezing Point Osmometer — ELITECHGROUP INC. · Class I
FreezePoint® Freezing Point Osmometer — ELITECHGROUP INC. · Class I
Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer — Advanced Instruments, LLC · Class I
OSMETTE III with Barcode Reader — PRECISION SYSTEMS, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Precision Systems, Inc.

Sources (1)

FDA UDI 43b45c61-9515-40bf-b102-9d914a1e9254 35 fields · synced May 30, 2026