FDA.reportPublic FDA data

S-Monovette®

Primary DI
04038917005784
Brand
S-Monovette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
01.1634
Catalog number
01.1634
Device description
S-Monovette® 7.5ml 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
04038917005784PackageGS1500In Commercial Distribution
04038917087322PrimaryGS10
04038917169233Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917005784040389170057844038917005784
04038917087322040389170873224038917087322
04038917169233040389171692334038917169233

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, lithium heparin/gel separatorA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant lithium heparin and a gel to separate plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)257-5101customerservice.us@sarstedt.com
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
50
DM exempt
false
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
04038917085519S-Monovette®-Needle85.116085.11602016-09-16
04038917086370S-Monovette®-Needle85.137285.13722016-09-16
04038917086387S-Monovette®-Needle85.137385.13732016-09-16
04038917086653S-Monovette®-Needle85.144085.14402016-09-16
04038917086660S-Monovette®-Needle85.144185.14412016-09-16
04038917126021Safety-Needle85.1160.20085.1160.2002016-09-16
04038917126045Safety-Needle85.1162.20085.1162.2002016-09-16
04038917127943Safety-Needle85.1372.20085.1372.2002016-09-16
04038917127950Safety-Needle85.1373.20085.1373.2002016-09-16
04038917129190Safety-Needle85.1440.20085.1440.2002016-09-16
04038917129206Safety-Needle85.1441.20085.1441.2002016-09-16
04038917250474Safety-Needle85.1162.60085.1162.6002016-09-16
04038917530590Safety-Needle 23Gx1"85.1442.20085.1442.2002025-05-02
04038917085526S-Monovette®-Needle85.116285.11622016-09-16
0403891739991310ml TBE 100x16 PP RED SCW CAP51.9923.83051.9923.8302023-01-18
04038917429948Tube 10ml, 100x16mm, PP62.9924.28062.9924.2802023-01-18
04066916044077Tube with cap, 82x13mm60.550.14160.550.1412025-09-26
04038917167918Haemo-Diff®14.121814.12182025-09-25
04038917983259S-Monovette® 1.6ml Serum CAT04.291104.29112025-09-25
04038917983280S-Monovette® 1.6ml Serum CAT04.2911.00104.2911.0012025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10386120014224RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
10386120014231RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
10386120014248RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
00810184642213GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
00810184642220GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
00810184642237GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
50382903678438BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection TubesBECTON, DICKINSON AND COMPANYJKA2026-01-27
20197344132918MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
20197344132925MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
00850073657041Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
00850073657065Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
10850073657024Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
00850073657027Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
20850074089067SurgycoSurgyco LLCJKA2025-12-23
20850074089074SurgycoSurgyco LLCJKA2025-12-23
20850074089081SurgycoSurgyco LLCJKA2025-12-23
20850074089098SurgycoSurgyco LLCJKA2025-12-23
20850074089104SurgycoSurgyco LLCJKA2025-12-23
20850074089111SurgycoSurgyco LLCJKA2025-12-23
00850058457031BD MiniDraw Capillary Tube Adapter SSTBabson Diagnostics, Inc.JKA2025-12-09
30351688010180PortexICU MEDICAL, INC.JKA2025-11-24
04038917983259S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983280S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983310S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983372S-Monovette® 1.6ml LHSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
040389179834021,6ml S-Monov. LiI-HEPSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983433S-Monovette® 1.6ml LHSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
20612479275649McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
20612479275670McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
20612479275700McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14