FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917125451
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1073.100
Catalog number
05.1073.100
Device description
S-Monovette® 2.7ml FE
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04038917020060PackageGS1500In Commercial Distribution
04038917125451PrimaryGS10
04038917199568Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917020060040389170200604038917020060
04038917125451040389171254514038917125451
04038917199568040389171995684038917199568

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, anticoagulant/antiglycolyticA non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), potassium oxalate, sodium heparin] and an antiglycolytic agent (e.g., sodium fluoride). 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 glucose or lactate 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917127653Microvette® CB 200 NC18.1325.10018.1325.1002022-11-30
04038917418263Twist cap for Microvette®65.1244.02865.1244.0282022-11-30
04038917418867Adapter sleeve14.121614.12162024-04-26
04038917988278Archiving Cap with filter65.647.32065.647.3202024-02-20
04038917113861UriSet 24 without acid77.578.01077.578.0102022-11-30
04038917927055Sediplus® S 2000 NX90.109290.10922022-11-30
04038917132176S-Monovette®03.1628.10003.1628.1002016-09-16
04038917431705S-Monovette®04.195204.19522019-09-30
04038917522793S-Monovette®04.1954.10004.1954.1002019-09-24
04038917522830S-Monovette®04.1952.10004.1952.1002019-09-24
04038917522878S-Monovette®04.1954.20004.1954.2002019-09-24
04038917522953S-Monovette®04.1953.20004.1953.2002019-09-24
04038917522991S-Monovette®04.1952.20004.1952.2002019-09-24
04038917523318S-Monovette®04.1953.10004.1953.1002019-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720466C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720558C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720237C-QuestLifeOutcomes LLCJKA2026-07-09
50192253051153CARDINAL HEALTHCardinal Health 200, LLCJKA2026-06-25
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17
10197344039708MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-16
10197344132911MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10197344132928MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10850074089060SurgycoSurgyco LLCJKA2025-12-23
10850074089077SurgycoSurgyco LLCJKA2025-12-23
10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
10850074089107SurgycoSurgyco LLCJKA2025-12-23