FDA.reportPublic FDA data

Redipor

Primary DI
00810144911182
Brand
Redipor
Company
AnalytiChem USA, Inc.
Model
1
Catalog number
T1660
Device description
0.85% Saline
Published
2023-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00810144911182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810144911182008101449111828101449111820810144911182

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

Regulatory Flags#

DUNS number
071749709
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810144911526Redipor1CHRP00382026-01-27
00810144911472Redipor12025-11-26
00810144911496Cell Pro1FTMT002025-11-26
00810144911502Cell Pro1BHIBT002025-11-26
00810144911519Cell Pro1T20052025-11-26
00810144911359Redipor1CHRP00262025-01-12
00810144911366Redipor1T20042024-05-15
00810144911007Redipor1T14752023-12-08
00810144911311Redipor1T30172023-12-08
00810144911328Redipor1T30192023-12-08
00810144911335Redipor1CHRP00162023-12-08
00810144911342Redipor1T14582023-12-08
00810144911304Redipor1T16542023-09-28
00810144910000Redipor12023-09-21
00810144910017Redipor1P15102023-09-21
00810144910024Redipor1P15512023-09-21
00810144910031Redipor1P11202023-09-21
00810144910048Redipor1P16402023-09-21
00810144910055Redipor1P10702023-09-21
00810144910062Redipor1P12502023-09-21

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
00810144911199RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911205RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911212RediporAnalytiChem USA, Inc.JCE2023-09-21
08719189137477RPI-CheckMechatronics USA LLCJCE2022-12-05
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