FDA.reportPublic FDA data

SARMIX®,GM1, 115V

Primary DI
04038917102193
Brand
SARMIX®,GM1, 115V
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
90.181.401
Catalog number
90.181.401
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GLEMIXER, BLOOD TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLEMixer, Blood TubeClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917102193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917102193040389171021934038917102193

GMDN Terms#

Term, Definition table
TermDefinition
Blood tube mixer IVDAn electrically-powered laboratory instrument intended to be used for the mixing of blood or other biological fluids contained in blood tubes or other similar specimen receptacles using continuous motion or agitation. It is typically used to provide movement that will prevent the blood from coagulating and/or to agitate the blood with movement for mixing with other solutions.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G0561003361Test Tubes, MacroBio/Data CorporationGLE2023-08-30
G0561015211Test Tubes, MicroBio/Data CorporationGLE2023-08-30
G0561068531Sample TubesBio/Data CorporationGLE2023-08-30
G0561068991Sample Tube CapsBio/Data CorporationGLE2023-08-30
04038917101974Sarmix®M2000,100-240V no rotorSarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
04038917141154Tube- Stripper AST-2Sarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
04038917258869Tube-Stripper AST-2SSarstedt Aktiengesellschaft & Co.KGGLE2022-11-30
00304040043387Henry ScheinHENRY SCHEIN, INC.GLE2022-05-03
00664816000151LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816001387LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816001585LW Scientific, Inc,LW SCIENTIFIC, INC.GLE2021-04-08
00664816003299LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816003800LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2021-04-08
00664816003794LW Scientific, Inc.LW SCIENTIFIC, INC.GLE2020-10-22
03661540304439ExcyteELITECHGROUP INC.GLE2018-12-26
03661540700446Excyte® ELITechGroup B.V.GLE2016-11-21