FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917134521
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
04.1932.001
Catalog number
04.1932.001
Device description
S-Monovette® 4.9ml K2E-Gel
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJEBlood/Plasma Collection Device For Dna Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJEBlood/Plasma Collection Device For Dna TestingClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917028868PackageGS1500In Commercial Distribution
04038917134521PrimaryGS10
04038917207133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917028868040389170288684038917028868
04038917134521040389171345214038917134521
04038917207133040389172071334038917207133

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, anticoagulant/separatorA non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., lithium heparin, ethylenediaminetetraacetic acid (EDTA)] and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). 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
50
DM exempt
true
Premarket exempt
false
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
04038917125154S-Monovette®02.1066.00102.1066.0012016-09-16
04038917125260S-Monovette®03.1068.10003.1068.1002016-09-16
04038917126243S-Monovette®05.1167.12005.1167.1202016-09-16
04038917131957S-Monovette®01.1605.00101.1605.0012016-09-16
04038917132039S-Monovette®01.1605.10001.1605.1002016-09-16
04038917132824S-Monovette®06.1664.10006.1664.1002016-09-16
04038917134170S-Monovette®04.1901.10004.1901.1002016-09-16
04038917134361S-Monovette®04.1914.10004.1914.1002016-09-16
04038917134514S-Monovette®04.1931.10004.1931.1002016-09-16
04038917238526S-Monovette®04.1917.10004.1917.1002016-09-16
04038917322737S-Monovette®06.1660.10006.1660.1002017-06-20
04038917350334S-Monovette®02.1066.10002.1066.1002016-09-16
04038917361668S-Monovette®05.1081.10005.1081.1002016-09-16
04038917370196S-Monovette®04.1931.01304.1931.0132016-09-16
04038917382250S-Monovette®04.1915.10004.1915.1002018-01-03
04038917311472RC 1200 S13 Hitachi, 115 V90.197.20190.197.2012022-11-30
04038917317658RC 1200 S 15 Hitachi, 115V90.197.10190.197.1012022-11-30
04038917536783DC 1200, Decapper Eurolab,115V90.198.51890.198.5182022-11-30
04038917546904RC 1200 Olympus AU5800, 115V90.197.03690.197.0362022-11-30
04038917547185RC 1200 S15 Olympus, 115V90.197.11190.197.1112022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
29120017577175VacuetteGreiner Bio-One GmbHPJE2023-12-15
04038917127677S-Monovette®Sarstedt Aktiengesellschaft & Co.KGPJE2019-09-17
04038917312707S-Monovette®Sarstedt Aktiengesellschaft & Co.KGPJE2018-10-11
29120017571876VacuetteGreiner Bio-One GmbHPJE2017-04-20
39120017571873VacuetteGreiner Bio-One GmbHPJE2017-04-20
29120017571425VacuetteGreiner Bio-One GmbHPJE2017-03-06
39120017571422VacuetteGreiner Bio-One GmbHPJE2017-03-06
29120017570855VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017570862VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571029VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571098VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571166VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571210VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571241VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571296VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571487VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571708VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571852VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571937VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571982VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017571999VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017572064VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017575683VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017575843VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576284VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576345VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576352VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576369VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576406VacuetteGreiner Bio-One GmbHPJE2016-09-23
29120017576413VacuetteGreiner Bio-One GmbHPJE2016-09-23