FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917133371
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1729.001
Catalog number
05.1729.001
Device description
S-Monovette® 2.7ml
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
04038917024853PackageGS1500In Commercial Distribution
04038917133371PrimaryGS10
04038917205535Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917024853040389170248534038917024853
04038917133371040389171333714038917133371
04038917205535040389172055354038917205535

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated blood collection tube IVD, no additiveA non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. 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
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
04038917133203S-Monovette®02.1726.00102.1726.0012016-09-16
04038917133326S-Monovette®01.1728.00101.1728.0012016-09-16
04038917134422S-Monovette®04.1926.00104.1926.0012016-09-16
04038917240895S-Monovette®05.172905.17292016-09-16
04038917567244S-Monovette®06.165906.16592020-08-17
04038917982429S-Monovette® 2.7ml05.1729.02105.1729.0212023-11-03
04038917133234S-Monovette®02.1726.02102.1726.0212017-02-08
04038917133241S-Monovette®02.1726.02202.1726.0222016-12-06
04038917085359Membrane-Adapter14.111214.11122016-09-16
04038917085793Multi-Adapter14.120514.12052016-09-16
04038917126663Multi-Adapter14.1205.05014.1205.0502016-09-16
04038917126700Multi-Adapter14.1205.10014.1205.1002016-09-16
04038917354776Blood Culture Adapter14.120914.12092016-09-16
04038917364188Blood Culture Adapter LongNeck14.120714.12072024-04-26
04066916046057PCMT 2ML ATC SAF BR 240/BG72.695.05172.695.0512026-10-14
04038917994224Micro tube 0.5ml, PP72.730.30572.730.3052024-09-23
04038917112529tube with screw cap 7ml, 82x13mm, PP60.550.04960.550.0492023-07-22
04038917413008tube with srew cap 5ml, 75x13mm, PP62.504.03962.504.0392023-07-22
04038917080873Push cap, neutral65.10965.1092022-11-30
04038917083492Push cap, neutral65.69765.6972022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS188470Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188480Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188490Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188500Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188510Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
B098AMS188520Aligned Medical SolutionsAligned Medical SolutionsJKA2026-10-12
06971564461696ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
06971564461702ITLJiangsu Caina Medical Co.,LtdJKA2026-09-30
00859776006033K-QUE-SAR-SHIPPERQuest DiagnosticsJKA2026-09-15
10197344216123MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-24
30382903679929BD Vacutainer® SST™ Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2026-07-20
10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216130MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216147MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216154MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216161MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216178MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
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