FDA.reportPublic FDA data

S-Monovette® POC Collect Kit

Primary DI
04038917398763
Brand
S-Monovette® POC Collect Kit
Company
SARSTEDT, INC.
Model
51.5100.100
Catalog number
51.5100.100
Device description
S-Monovette® POC Collect Kit
Published
2017-07-28
Public version status
Update
Distribution status
Not 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
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917398756PackageGS150In Commercial Distribution
04038917398763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917398756040389173987564038917398756
04038917398763040389173987634038917398763

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of sterile devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
035410179
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917087841Tissue Culture Coverslip 25 mm83.18402022-11-22
04038917134040Tissue Culture Coverslip 22 mm83.1840.0012022-11-22
04038917134057Tissue Culture Coverslip 13 mm83.1840.0022022-11-22
04038917398220"Tourniquet Single Use NL Flat, 1"""95.1007.1012023-06-06
04038917554633Screw Cap Tube 101x16 RBS with saline51.540.3872022-12-04
04038917554671Screw Cap Tube 82x13 FB with saline51.550.1232022-12-04
04038917952569Screw Cap Tube 79x16 RB with saline51.506.3902022-12-04
04038917554640Screw Cap Tube 101x16 RBS with saline51.540.3872022-12-04
04038917554688Screw Cap Tube 82x13 FB with saline51.550.1232022-12-04
04038917952552Screw Cap Tube 79x16 RB with saline51.506.3902022-12-04
04038917033435Screw Cap Tube 120x17 mm, 15 ml, PS62.553.0022022-11-22
04038917033442Screw Cap Tube 120x17 mm, 15 ml, PS62.553.2052022-11-22
04038917033497Screw Cap Tube 120x17 mm, 15 ml, PP62.554.2052022-11-22
04038917075671Urine Monovette®, 10ML with luerlock10.252.0282022-11-22
04038917376334Screw Cap Tube 120x17 mm, 15 ml, PP62.554.1002022-11-22
04038917112949Screw Cap Tube 120x17 mm, 15 ml, PS62.553.0022022-11-22
04038917112987Screw Cap Tube 120x17 mm, 15 ml, PS62.553.2052022-11-22
04038917113144Screw Cap Tube 120x17 mm, 15 ml, PP62.554.2052022-11-22
04038917104494Urine Monovette®, 10ML with luerlock10.252.0282022-11-22
04038917006095Tissue Culture Coverslip 25 mm83.18402022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-05-06
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04
00810010894991Aero-MedAERO-MED, LLCPQD2026-04-07
00810010895004Aero-MedAERO-MED, LLCPQD2026-04-07
10885380211225Aero-MedAERO-MED, LLCPQD2026-03-20
50885380211223Aero-MedAERO-MED, LLCPQD2026-03-20
00850070635158KIT, BLOOD CULTURE COLLECTINGNar Medical Depot, LLCPQD2026-03-19
00810010894885Aero-MedAERO-MED, LLCPQD2026-03-17
50810010894880Aero-MedAERO-MED, LLCPQD2026-03-17
00810010894960Aero-MedAERO-MED, LLCPQD2026-03-17
00850066710272Simple HealthKitSIMPLE HEALTHKIT, INC.PQD2026-01-21
04779054721198RDA SpotRDA SPOT, UABPQD2026-01-15
00850015884351easycareSynchronis Medical, LLCPQD2026-01-07
00850015884368easycareSynchronis Medical, LLCPQD2026-01-07
04779054721129RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721143RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721082BLOODORDA SPOT, UABPQD2025-10-16
04779054721105BLOODORDA SPOT, UABPQD2025-10-16
04779054721112BLOODORDA SPOT, UABPQD2025-10-16
04779054721099BLOODORDA SPOT, UABPQD2025-10-13
04779054720276ZinzinoRDA SPOT, UABPQD2025-10-03
04779054720184ZinzinoRDA SPOT, UABPQD2025-09-16
04779054721013ZinzinoRDA SPOT, UABPQD2025-07-24
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07