FDA.reportPublic FDA data

Urine Monovette®, 10ML with luerlock

Primary DI
04038917075671
Brand
Urine Monovette®, 10ML with luerlock
Company
SARSTEDT, INC.
Model
10.252.028
Device description
Urine Monovette®, 10ML with luerlock adapter assembled
Published
2022-11-22
Public version status
New
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
KDTContainer, Specimen Mailer And Storage, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917075671PrimaryGS10
04038917104494Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917075671040389170756714038917075671
04038917104494040389171044944038917104494

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated urine specimen container IVD, no additiveA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
035410179
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917398763S-Monovette® POC Collect Kit51.5100.10051.5100.1002017-07-28
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
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
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
04038917310932Biosphere® screw cap, whiteSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917326681Biosphere® Screw Cap, greenSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917328272Biosphere® screw cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917369893Biosphere® Screw Cap, redSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411752Biosphere® screw cap, yellowSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411783Biosphere® Screw Cap, violetSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411813Biosphere® Screw Cap, blueSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411844Biosphere® Screw Cap, blackSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411875Biosphere® screw cap, neutralSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
0406691600599325 ml tube 90x 25Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-28
04066916018412urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
04038917923446Srew cap, pinkSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917923507Srew cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917994576SC MTube 0,5 mlSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917242561Tube 50ml, 114x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-16
04038917113571Tube 50ml, 115x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-07
04038917408561Tube 5ml, 75x13mmSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917994224Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917996556Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917432146Tube 39 x 13Sarstedt Aktiengesellschaft & Co.KGKDT2024-05-22
0403891736995410ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
04038917989657Screw cap.134GD BRAUN BIO.VD VZ50Sarstedt Aktiengesellschaft & Co.KGKDT2024-02-20
04038917112970Tube 15ml, 120x17mm, PSSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917113007Tube 15ml, 120x17mm, PSSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917565103Tube 15ml, 120x17mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917112529tube with screw cap 7ml, 82x13mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-07-22
04038917238649Tube 25ml 90x25PP+ CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-19