Rpi

FDA UDI

Class I (US FDA UDI)

by Mechatronics Usa

Identity

Trade Name: RPI FDA UDI
Generic Name: Isotonic saline reagent IVD FDA UDI
Device Name: Reagent Production Instrument FDA UDI
Model / Reference: A0021587 FDA UDI
Description: Reagent Production Instrument FDA UDI

Identifiers

Primary DI / UDI-DI: 08719189137347 FDA UDI
FDA Product Code: LXG FDA UDI
GMDN Term: Isotonic saline reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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

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

Sterilization Method

Liquid Chemical FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Isotonic saline reagent IVD

Rpi by Mechatronics Usa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Isotonic saline reagent IVD.

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Screw Cap Tube 101x16 RBS with saline — SARSTEDT, INC. · Class I
Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
Thermo Scientific Nerl® — Fisher Diagnostics · Class I
ACE — Alfa Wassermann, Inc.
SP — Cardinal Health 200, LLC · 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: Mechatronics Usa

Sources (1)

FDA UDI 2b92da2e-d1c7-4b7f-af31-e330daf0ff03 34 fields · synced May 29, 2026