RPI-Check

GUDID 08719189137538

Reagent for instrument

Mechatronics USA LLC

Isotonic saline reagent IVD
Primary Device ID08719189137538
NIH Device Record Key5eae7830-ff11-44a2-8d8e-8936a3da1ea2
Commercial Distribution StatusIn Commercial Distribution
Brand NameRPI-Check
Version Model NumberA0016912
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS108719189137477 [Primary]
GS108719189137538 [Package]
Contains: 08719189137477
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

JCESOLUTION, ISOTONIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

Liquid Chemical


[08719189137538]

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 - RPI2022-12-13 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

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