FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917134293
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
04.1907.100
Catalog number
04.1907.100
Device description
S-Monovette® 2.6ml LH-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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917025607PackageGS1500In Commercial Distribution
04038917134293PrimaryGS10
04038917206907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917025607040389170256074038917025607
04038917134293040389171342934038917134293
04038917206907040389172069074038917206907

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
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
04038917134316S-Monovette®04.1910.00104.1910.0012019-09-17
04038917087322S-Monovette®01.163401.16342016-09-16
04038917125147S-Monovette®02.1065.00102.1065.0012016-09-16
04038917130431S-Monovette®05.1553.10005.1553.1002016-09-16
04038917131919S-Monovette®01.1604.10001.1604.1002016-09-16
04038917131926S-Monovette®01.1604.40001.1604.4002016-09-16
04038917132084S-Monovette®01.1608.10001.1608.1002016-09-16
04038917132107S-Monovette®01.1613.10001.1613.1002016-09-16
04038917132114S-Monovette®01.1614.10001.1614.1002022-09-12
04038917132176S-Monovette®03.1628.10003.1628.1002016-09-16
04038917132213S-Monovette®03.1631.10003.1631.1002016-09-16
04038917132251S-Monovette®01.1634.10001.1634.1002016-09-16
04038917132886S-Monovette®06.1666.10006.1666.1002016-09-16
04038917132930S-Monovette®06.1669.00106.1669.0012016-09-16
04038917134279S-Monovette®04.1906.10004.1906.1002016-09-16
04038917134330S-Monovette®04.1913.10004.1913.1002016-09-16
04038917134378S-Monovette®04.1920.10004.1920.1002016-09-16
04038917134767S-Monovette®04.1936.10004.1936.1002016-09-16
04038917241779S-Monovette®04.1940.10004.1940.1002016-09-16
04038917266888S-Monovette®04.1929.10004.1929.1002016-09-16

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