FDA.reportPublic FDA data

ESR-Vacuum tubes

Primary DI
10844509000027
Brand
ESR-Vacuum tubes
Company
STRECK, INC.
Model
240216
Catalog number
240216
Device description
High altitude tri-sodium citrate blood collection tubes case contains 1200 vials.
Published
2016-09-19
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
10844509000027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084450900002710844509000027

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, sodium citrateA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., for plasma coagulation studies, mononuclear cell preparation). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.2Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-228-6090custserv@streck.com

Regulatory Flags#

DUNS number
072915986
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20844509000314Cal-Chex A Plus 2211062211062016-09-16
30844509000311Cal-Chex A Plus 2211072211072016-09-16
40844509000318Cal-Chex A Plus2211082211082016-09-16
20844509000338STaK-Chex Plus Retics2254812254812016-09-19
00844509001379CVA2915042915042016-09-16
00844509001386CVA2917082917082016-09-16
00844509001393CVA2917092917092016-09-16
00844509001409CVA2917102917102016-09-16
00844509001416CVA2917112917112016-09-16
00844509001423CVA2917122917122016-09-16
00844509001430CVA2917132917132016-09-16
00844509001447CVA2917142917142016-09-16
00844509001560CVA for CellDyn 2917152917152016-09-16
00844509001577CVA for CellDyn 2917182917182016-09-16
00844509001584CVA for CellDyn 2917192917192016-09-16
00844509001591CVA for CellDyn 2917202917202016-09-16
00844509001669CVA2917222917222016-09-16
20844509000246Cal-Chex2211012211012016-09-16
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16

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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
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00840095605984Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
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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
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
00844509000068ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19