FDA.reportPublic FDA data

RPI-Check

Primary DI
08719189137477
Brand
RPI-Check
Company
Mechatronics USA LLC
Model
A0016912
Device description
Reagent for instrument
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCESOLUTION, ISOTONIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCESolution, IsotonicPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719189137538PackageGS112In Commercial Distribution
08719189137477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189137538087191891375388719189137538
08719189137477087191891374778719189137477

GMDN Terms#

Term, Definition table
TermDefinition
Isotonic saline reagent IVDAn unbuffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
+1 401 431-6101salesusa@rrmechatronics.com

Regulatory Flags#

DUNS number
137005943
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719189137781StarrsedA00301122024-08-26
08719189137286StarrsedA00263762022-12-05
08719189137293StarrsedA00263762022-12-05
08719189137347RPIA00215872022-12-05
08719189137361StarrsedA00263762022-12-05
08719189137378StarrsedA00263762022-12-05
08719189137385StarrsedA00263762022-12-05
08719189137392StarrsedA00263762022-12-05
08719189137446StarrsedA00263762022-12-05
08719189137453StarrsedA00263762022-12-05
08719189137460StarrsedA00263762022-12-05
08719189137538RPI-CheckA00169122022-12-05
08719189137729StarrsedA00263762022-12-05
08719189137736StarrsedA00263762022-12-05
08719189137750StarrsedA00263522022-12-05
08719189137767StarrsedA00263762022-12-05
08719189137774StarrsedA00263762022-12-05
08719189137743StarrsedA00263762022-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810144911304RediporAnalytiChem USA, Inc.JCE2023-09-28
00810144911168RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911175RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911182RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911199RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911205RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911212RediporAnalytiChem USA, Inc.JCE2023-09-21
08719189137538RPI-CheckMechatronics USA LLCJCE2022-12-05
00845275004366Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-08-26
00845275004342Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-08-13
00845275004656Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-07-31
00845275004663Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-07-31