RPI

GUDID 08719189137347

Reagent Production Instrument

Mechatronics USA LLC

Isotonic saline reagent IVD
Primary Device ID08719189137347
NIH Device Record Key2b92da2e-d1c7-4b7f-af31-e330daf0ff03
Commercial Distribution StatusIn Commercial Distribution
Brand NameRPI
Version Model NumberA0021587
Company DUNS137005943
Company NameMechatronics USA LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com
Phone+1 401 431-6101
Emailsalesusa@rrmechatronics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108719189137347 [Primary]

FDA Product Code

LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


[08719189137347]

Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

Devices Manufactured by Mechatronics USA LLC

08719189137781 - Starrsed2024-09-03 Automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in conformity
08719189137286 - Starrsed2022-12-13 Semi-automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in confor
08719189137293 - Starrsed2022-12-13 DXH-800
08719189137347 - RPI2022-12-13Reagent Production Instrument
08719189137347 - RPI2022-12-13 Reagent Production Instrument
08719189137361 - Starrsed2022-12-13 LH750
08719189137378 - Starrsed2022-12-13 long, black
08719189137385 - Starrsed2022-12-13 (Advia)
08719189137392 - Starrsed2022-12-13 DXH-800

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.