FDA.reportPublic FDA data

Monovette®

Primary DI
04038917085458
Brand
Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
05.1147
Catalog number
05.1147
Device description
Monovette® 2ml LH blood gas
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
04038917004121PackageGS1500In Commercial Distribution
04038917085458PrimaryGS10
04038917167543Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917004121040389170041214038917004121
04038917085458040389170854584038917085458
04038917167543040389171675434038917167543

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
04038917542500S-Monovette®04.1951.10004.1951.1002026-11-05
04038917085465Ventilation14.114814.11482016-09-16
04038917125956Monovette® 2ml LH05.1147.00805.1147.0082024-10-07
04038917125963Monovette®05.1147.02005.1147.0202016-09-16
04038917247221Monovette®05.114605.11462016-09-16
04038917247252Monovette®05.1146.02005.1146.0202016-09-16
04038917280679Monovette®05.1147.02805.1147.0282016-09-16
04038917408615Monovette® 1ml LH05.1146.00805.1146.0082024-10-07
04038917125970Monovette®05.1147.04805.1147.0482019-12-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038917542500S-Monovette®Sarstedt Aktiengesellschaft & Co.KGJKA2026-11-05
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