FDA.reportPublic FDA data

V-Monovette® Urine Z 4ml

Primary DI
04038917244824
Brand
V-Monovette® Urine Z 4ml
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
11.2252.001
Catalog number
11.2252.001
Published
2022-11-30
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
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
04038917244824PrimaryGS10
04038917244831Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917244824040389172448244038917244824
04038917244831040389172448314038917244831

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated urine specimen container IVD, no additiveA covered receptacle containing a pre-measured amount of vacuum 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 in vitro diagnostic 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04038917084093Push cap, neutral65.78265.7822022-11-30
04038917112963Tube 15ml, 120x17mm, PS62.553.04162.553.0412023-11-07
04038917112970Tube 15ml, 120x17mm, PS62.553.04262.553.0422023-11-07
04038917113007Tube 15ml, 120x17mm, PS62.553.54262.553.5422023-11-07
04038917113571Tube 50ml, 115x28mm, PP62.559.01062.559.0102024-10-07
04038917150880Tube 5ml 50x16PS +Cap NAT63.9921.53563.9921.5352023-01-18
04038917151139Tube 10ml 97x16PS+Cap60.9921.83060.9921.8302023-01-18
04038917151528Tube 25ml 90x25PP+Cap60.9922.24360.9922.2432023-01-18
04038917151573Tube 25ml 90x25PP+Cap63.9922.25463.9922.2542023-01-18
04038917155120Tube 10ml, 100x16mm, PP62.9924.27262.9924.2722023-01-18
04038917155137Tube 10ml, 100x16, PP62.9924.27362.9924.2732023-01-18
04038917155144Tube 10ml, 100x16, PP62.9924.27462.9924.2742023-01-18
04038917155182Tube 10ml 100x16PP+Cap62.9924.28362.9924.2832023-01-18
04038917155199Tube 10ml, 100x16mm, PP62.9924.28462.9924.2842023-01-18
04038917155472Set of 4 Tube 12ml 99x16mm60.9924.95260.9924.9522023-01-18
04038917238649Tube 25ml 90x25PP+ Cap63.9922.24863.9922.2482023-01-19
04038917242561Tube 50ml, 114x28mm, PP62.547.27462.547.2742024-10-16
04038917253468Tube 25ml 90x25PP+ Cap60.9922.26060.9922.2602023-01-18
04038917260008Tube 5 ml, 75 x 13 mm , PP55.525.06055.525.0602024-10-24

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
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
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
0403891736995410ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
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
04038917238649Tube 25ml 90x25PP+ CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-19
04038917151528Tube 25ml 90x25PP+CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917151573Tube 25ml 90x25PP+CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917155144Tube 10ml, 100x16, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917155199Tube 10ml, 100x16mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917155472Set of 4 Tube 12ml 99x16mmSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917389112Tube 10ml 100x16 PP + CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917429931Tube 10ml, 100x16mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
14039943000016CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000023CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000030CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000047CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000054CRYO.SGreiner Bio - One GmbHKDT2022-12-06