FDA.reportPublic FDA data

ESR pipette without graduation

Primary DI
04038917088138
Brand
ESR pipette without graduation
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
86.1996
Catalog number
86.1996
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
04038917088138PrimaryGS10
04038917169943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917088138040389170881384038917088138
04038917169943040389171699434038917169943

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.

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
100
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04038917423793Multifly®-Needle85.1640.03585.1640.0352019-10-06
04038917423885Safety-Multifly®-Needle85.1638.20085.1638.2002019-09-30
04038917423915Safety-Multifly®-Needle85.1638.20585.1638.2052019-09-30
04038917423922Safety-Multifly®-Needle85.1638.23585.1638.2352019-09-30
04038917423939Safety-Multifly®-Needle85.1640.20085.1640.2002019-09-30
04038917423960Safety-Multifly®-Needle85.1640.20585.1640.2052019-09-30
04038917423977Safety-Multifly®-Needle85.1640.23585.1640.2352019-09-30
04038917423991Safety-Multifly®-Needle85.1642.20585.1642.2052019-09-30
04038917424004Safety-Multifly®-Needle85.1642.23585.1642.2352019-09-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810160810414Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
10810160810411Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
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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
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