FDA.reportPublic FDA data

PC

Primary DI
00026072023716
Brand
PC
Company
Allied Medical, LLC
Model
S2020
Device description
CLINICAL REFRACTOMETER
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JRERefractometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRERefractometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00026072023716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072023716000260720237160260720237160026072023716

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed medical gas cylinder regulatorA reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

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Primary DI, Brand, Company table
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20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JRE2025-09-18
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00850054026729QMedix™Diagnostic Automation, Inc.JRE2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JRE2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJRE2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJRE2024-06-05
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08806141303497One+Step 10ADFI CO.,LTDJRE2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JRE2023-06-08
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10885380175589CARDINAL HEALTHCardinal Health 200, LLCJRE2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJRE2020-06-30
08806141302070CYBOW 10DFI CO.,LTDJRE2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJRE2020-03-09
08806141301998Yodoc 10DFI CO.,LTDJRE2020-02-20
00722066001219Rapid ResponseBTNX IncJRE2019-10-16
00722066001936Rapid ResponseBTNX IncJRE2019-10-16