FDA.reportPublic FDA data

Vacuette

Primary DI
39120017578155
Brand
Vacuette
Company
Greiner Bio-One GmbH
Model
727111
Catalog number
727111
Device description
ESR pipette with adapter, graduated 200 mm for 454073
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JPHTEST, ERYTHROCYTE SEDIMENTATION RATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPHTest, Erythrocyte Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
39120017578155PackageGS14In Commercial Distribution
29120017578158PrimaryGS10
19120017578151Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3912001757815539120017578155
2912001757815829120017578158
1912001757815119120017578151

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated erythrocyte sedimentation rate (ESR) tube IVDAn open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303639066
Device count
200
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
29120126131404VACUETTE4530474530472026-01-26
29120126131411VACUETTE4530484530482026-01-26
29120126131428VACUETTE4530494530492026-01-26
29120126131466VACUETTE4530464530462026-01-26
29120126131459VACUETTE4530454530452025-04-02
39120049209317Vacuette4560084560082025-03-25
39120049209324Vacuette4550244550242025-03-25
39120049209331Vacuette4550234550232025-03-25
29120126131008VACUETTE7243257243252024-07-23
39120126131012VACUETTE455043P455043P2024-07-02
39120126130978VACUETTE484493P484493P2024-05-14
39120126130985VACUETTE486073P486073P2024-05-14
39120126130992VACUETTE4860894860892024-05-14
39120017577172Vacuette4845074845072023-12-15
39120017579374Vacuette4845184845182023-12-15
39120049208143Vacuette4845284845282023-12-15
29120049209952Vacuette450161V1450161V12023-12-11
29120049208719Vacuette450081V1450081V12023-12-07
29120049208726Vacuette450082V1450082V12023-12-07
29120049208740Vacuette450084V1450084V12023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810160810411Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
00860011967712ZELLESR-10STERILE SAFEQUIP & CHEMICALS LLPJPH2024-07-07
00840095624565Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682411Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
04038917085205ESR rack for Monovette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085304ESR rack for S-Sedivette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085311ESR rack for Microvette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917169943ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917207607ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
08033891321017ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891321048ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328207ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328757ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
39120017578179VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578186VacuetteGreiner Bio-One GmbHJPH2020-09-30
07612964013113DISPETTE®Guest Scientific AGJPH2020-06-01
07612964000809DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013311DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013335DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013410DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013540DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013656DISPETTE®Guest Scientific AGJPH2019-11-07
50885380168541CARDINAL HEALTHCardinal Health 200, LLCJPH2019-06-07
50885380168558CARDINAL HEALTHCardinal Health 200, LLCJPH2019-06-07
00847661003090LiquichekBIO-RAD LABORATORIES, INC.JPH2017-01-12
00847661003106LiquichekBIO-RAD LABORATORIES, INC.JPH2017-01-12
00847661003113LiquichekBIO-RAD LABORATORIES, INC.JPH2017-01-12
20844509001601ESR-Chex STRECK, INC.JPH2016-09-19
20844509001618ESR-Chex STRECK, INC.JPH2016-09-19
00844509001621ESR-Chex STRECK, INC.JPH2016-09-19