FDA.reportPublic FDA data

S-Sedivette®

Primary DI
04038917133128
Brand
S-Sedivette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
06.1690.100
Catalog number
06.1690.100
Device description
S-Sedivette® 3.5ml 4NC
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GHCTUBE, SEDIMENTATION RATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHCTube, Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917024716PackageGS1500In Commercial Distribution
04038917133128PrimaryGS10
04038917205313Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917024716040389170247164038917024716
04038917133128040389171331284038917133128
04038917205313040389172053134038917205313

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated erythrocyte sedimentation rate (ESR) tube IVDA sterile glass or plastic tube sealed with a stopper, or other dedicated vessel, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled measure) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917530552S-Monovette®-Needle 23Gx1"85.144285.14422025-10-22
04038917086318Urine receptacle 500ml75.135675.13562025-05-19
04038917927048Sediplus® S 2000 NX90.109290.10922026-07-22
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PS95.1000.47695.1000.4762026-07-21
04038917124935ESR RACK N/BACK PANEL90.1060.06290.1060.0622026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CB95.1000.47795.1000.4772026-07-21
04038917581882Salivette®51.1534.10051.1534.1002026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04066916055837Screw cap, pastel-green65.716.04565.716.0452026-07-21
04066916055998Screw cap, pastel-orange65.716.04665.716.0462026-07-21
04066916056049Screw cap, pastel-violet65.716.04865.716.0482026-07-21
04066916056148Screw cap, pastel-yellow65.716.04265.716.0422026-07-21
04066916056407Screw cap, pastel-blue65.716.04165.716.0412026-07-21
04066916057831SafeSeal tube 0.5ml72.704.05072.704.0502026-07-21
04066916057879SafeSeal tube 0.5ml, brown72.704.05172.704.0512026-07-21
04066916058012SafeSeal tube 0.5ml, red72.704.05272.704.0522026-07-21
04066916058050SafeSeal tube 0.5ml, yellow72.704.05472.704.0542026-07-21
04066916058135SafeSeal tube 0.5ml, green72.704.05572.704.0552026-07-21
04066916058173SafeSeal tube 0.5ml, blue72.704.05672.704.0562026-07-21
04066916058210Micro tube 0.5ml SafeSeal72.704.45072.704.4502026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891320522VACU-TECDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891320645VACU-TEC CUVETTE-LDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891320690VES-TEC CUVETTE-LDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891321086VACU-TEC S.C.DIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891321093VACU-TEC S.C. STERILEDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
04038917127653Microvette® CB 200 NCSarstedt Aktiengesellschaft & Co.KGGHC2022-11-30
04038917201360Microvette® CB 200 NCSarstedt Aktiengesellschaft & Co.KGGHC2022-11-30
08033891320546VACU-TEC DOUBLE LABELDIESSE DIAGNOSTICA SENESE SPAGHC2022-11-25
08033891320577VES-TECDIESSE DIAGNOSTICA SENESE SPAGHC2022-11-25
00840095605939Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605946Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605960Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605977Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605984Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095606004Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095606028Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095606059Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
03661540700606Excyte® ELITechGroup B.V.GHC2016-11-24
03661540700613Excyte® ELITechGroup B.V.GHC2016-11-24
03661540700668Excyte® ELITechGroup B.V.GHC2016-11-24
03661540700675Excyte® ELITechGroup B.V.GHC2016-11-24
29120017575263VacuetteGreiner Bio-One GmbHGHC2016-09-23
39120017575260VacuetteGreiner Bio-One GmbHGHC2016-09-23
10844509000003ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
10844509000027ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
10844509000041ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
10844509000065ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000006ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000020ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000044ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19