FDA.reportPublic FDA data

Starrsed Cleaning Agent

Primary DI
08719189137132
Brand
Starrsed Cleaning Agent
Company
RR Mechatronics Manufacturing B.V.
Model
QRR010905
Device description
Product for cleaning pipettes in Starrsed ESR analyzers
Published
2023-07-25
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
GKBDEVICE, AUTOMATED SEDIMENTATION RATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719189137132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719189137132087191891371328719189137132

GMDN Terms#

Term, Definition table
TermDefinition
Buffered wash solution IVDA buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

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

Regulatory Flags#

DUNS number
491828953
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
08719189137194Starrsed DiluentQRR0109312023-07-25
08719189137217Starrsed Rinse SolutionQRR0109342023-07-25
08719189137224Starrsed X-CleanQRR0109462023-07-25
08719189137231Starrsed DisinfectantQRR0109472023-07-25
08719189137200Starrsed SalineQRR0109332023-07-24
08719189137149Starrsed ControlQRR0490012022-12-05
08719189137170Starrsed ControlQRR0490022022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719189137781StarrsedMechatronics USA LLCGKB2024-08-26
00860011967736ZBT-ESRSTERILE SAFEQUIP & CHEMICALS LLPGKB2024-07-09
00868556000208ESR STAT 6Airscan, Inc.GKB2024-06-04
08033891324551VES-MATIC ORIGINALDIESSE DIAGNOSTICA SENESE SPAGKB2023-12-14
00850028040041iSED EliteALCOR SCIENTIFIC INC.GKB2023-11-03
03661540300035Microsed-System® Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300202Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300240Excyte® ESR Non-Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300257Excyte® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300264Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300271Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
08719189137217Starrsed Rinse SolutionRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137224Starrsed X-CleanRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137231Starrsed DisinfectantRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137200Starrsed SalineRR Mechatronics Manufacturing B.V.GKB2023-07-24
06936895301097BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GKB2023-07-05
08719189137149Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137170Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137286StarrsedMechatronics USA LLCGKB2022-12-05
08719189137293StarrsedMechatronics USA LLCGKB2022-12-05
08719189137361StarrsedMechatronics USA LLCGKB2022-12-05
08719189137378StarrsedMechatronics USA LLCGKB2022-12-05
08719189137385StarrsedMechatronics USA LLCGKB2022-12-05
08719189137392StarrsedMechatronics USA LLCGKB2022-12-05
08719189137446StarrsedMechatronics USA LLCGKB2022-12-05
08719189137453StarrsedMechatronics USA LLCGKB2022-12-05
08719189137460StarrsedMechatronics USA LLCGKB2022-12-05
08719189137729StarrsedMechatronics USA LLCGKB2022-12-05