FDA.reportPublic FDA data

RPI-Check

Primary DI
08719189137538
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
Rx
false
OTC
false
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719189137781StarrsedA00301122024-08-26
08719189137477RPI-CheckA00169122022-12-05
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
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
08719189137477RPI-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