FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917126243
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1167.120
Catalog number
05.1167.120
Device description
S-Monovette® 2.7ml K3E
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
04038917020527PackageGS1500In Commercial Distribution
04038917126243PrimaryGS10
04038917200165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917020527040389170205274038917020527
04038917126243040389171262434038917126243
04038917200165040389172001654038917200165

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, anticoagulantA non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), lithium heparin, sodium citrate]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening, plasma coagulation studies and/or and quantitative drug assay 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
100
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
04038917125154S-Monovette®02.1066.00102.1066.0012016-09-16
04038917125260S-Monovette®03.1068.10003.1068.1002016-09-16
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
04038917134521S-Monovette®04.1932.00104.1932.0012016-09-16
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

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