Osmette Xl

FDA UDI

Class I (US FDA UDI)

by Precision Systems, Inc.

Identity

Trade Name: OSMETTE XL FDA UDI
Generic Name: Osmometric analyser IVD FDA UDI
Device Name: Precision Systems OSMETTE XL osmometer, 220 V FDA UDI
Model / Reference: 5007F FDA UDI
Description: Precision Systems OSMETTE XL osmometer, 220 V FDA UDI

Identifiers

Catalog Number: 5007F FDA UDI
Primary DI / UDI-DI: 00850041049779 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 Xl by Precision Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Precision Systems, Inc.

Sources (1)

FDA UDI 64dab922-360f-4d4f-ae5b-ec82a1f52da6 35 fields · synced May 30, 2026