FDA.reportPublic FDA data

DISPETTE®

Primary DI
07612964013304
Brand
DISPETTE®
Company
Guest Scientific AG
Model
FH1600
Catalog number
FH1600
Device description
DISPETTE 2 SALINE
Published
2019-11-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
07612964013311PackageGS110Not in Commercial Distribution
07612964013304PrimaryGS10
07612964013342Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612964013311076129640133117612964013311
07612964013304076129640133047612964013304
07612964013342076129640133427612964013342

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) IVD, kitA collection of reagents and other associated materials intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Regulatory Flags#

DUNS number
483342734
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612964000762DISPETTE®FH1650FH16502019-11-07
07612964013106DISPETTE®FH1500FH15002020-06-01
07612964013403DISPETTE®FH1800FH18002019-11-07
07612964013533DISPETTE®FH1530FH15302019-11-07
07612964013113DISPETTE®FH1500FH15002020-06-01
07612964013656DISPETTE®FH1705FH17052019-11-07
07612964013328DISPETTE®FH1500FH15002019-11-07
07612964000809DISPETTE®FH1650FH16502019-11-07
07612964013311DISPETTE®FH1600FH16002019-11-07
07612964013335DISPETTE®FH1500FH15002019-11-07
07612964013410DISPETTE®FH1800FH18002019-11-07
07612964013540DISPETTE®FH1530FH15302019-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810160810414Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
10810160810411Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
00860011967712ZELLESR-10STERILE SAFEQUIP & CHEMICALS LLPJPH2024-07-07
00840095624572Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682404Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095624565Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682411Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
04038917088138ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917135047ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
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
29120017578172VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578189VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578179VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578186VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578158VacuetteGreiner Bio-One GmbHJPH2020-09-25
39120017578155VacuetteGreiner Bio-One GmbHJPH2020-09-25
07612964013106DISPETTE®Guest Scientific AGJPH2020-06-01
07612964013113DISPETTE®Guest Scientific AGJPH2020-06-01
07612964000762DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013328DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013403DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013533DISPETTE®Guest Scientific AGJPH2019-11-07