FDA.reportPublic FDA data

Sediplus® S 2000 NX

Primary DI
04038917927055
Brand
Sediplus® S 2000 NX
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
90.1092
Catalog number
90.1092
Published
2022-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04038917927055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917927055040389179270554038917927055

GMDN Terms#

Term, Definition table
TermDefinition
Erthrocyte sedimentation rate (ESR) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917113861UriSet 24 without acid77.578.01077.578.0102022-11-30
04038917132176S-Monovette®03.1628.10003.1628.1002016-09-16
04038917431705S-Monovette®04.195204.19522019-09-30
04038917522793S-Monovette®04.1954.10004.1954.1002019-09-24
04038917522830S-Monovette®04.1952.10004.1952.1002019-09-24
04038917522878S-Monovette®04.1954.20004.1954.2002019-09-24
04038917522953S-Monovette®04.1953.20004.1953.2002019-09-24
04038917522991S-Monovette®04.1952.20004.1952.2002019-09-24
04038917523318S-Monovette®04.1953.10004.1953.1002019-09-21
04038917240345Safety-Multifly®-Needle85.1638.93585.1638.9352016-09-16
04038917281812Micro-Needle85.92385.9232016-09-16
04038917281843Micro-Needle85.92585.9252016-09-16
04038917315517Micro-Needle85.92185.9212016-09-16
04038917423410Safety-Multifly® 23G w.holder85.1640.93585.1640.9352024-02-20
04038917423892Safety-Multifly®-Needle85.1638.20185.1638.2012019-12-13
04038917423724Multifly®-Needle85.163885.16382019-10-06
04038917423755Multifly®-Needle85.1638.00185.1638.0012019-10-06
04038917423762Multifly®-Needle85.1638.00585.1638.0052019-10-06
04038917423779Multifly®-Needle85.1638.03585.1638.0352019-10-06
04038917423786Multifly®-Needle85.1640.00585.1640.0052019-10-06

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
03661540300288Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300202Monosed® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300257Excyte® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300264Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
03661540300271Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
08719189137132Starrsed Cleaning AgentRR Mechatronics Manufacturing B.V.GKB2023-07-25
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
08719189137118Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137125Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137149Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137170Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137286StarrsedMechatronics USA LLCGKB2022-12-05