FDA.reportPublic FDA data

Urine cup with transfer device

Primary DI
04038917236812
Brand
Urine cup with transfer device
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
75.562.400
Catalog number
75.562.400
Published
2022-11-30
Public version status
New
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
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
04038917236805PrimaryGS10
04038917236812Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917236805040389172368054038917236805
04038917236812040389172368124038917236812

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
388000270
Device count
200
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
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
B686600050ProteX with FlightLock TechnologyRSI Technology Group, LLCKDT2026-04-01
B686600061ProteX with FlightLock TechnologyRSI Technology Group, LLCKDT2026-04-01
04066916044077Tube with cap, 82x13mmSarstedt Aktiengesellschaft & Co.KGKDT2025-09-26
04038917310949Biosphere® screw cap, whiteSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917326698Biosphere® Screw Cap, greenSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917328289Biosphere® screw cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917369909Biosphere® Screw Cap, redSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411769Biosphere® screw cap, yellowSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411790Biosphere® Screw Cap, violetSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411820Biosphere® Screw Cap, blueSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411851Biosphere® Screw Cap, blackSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
04038917411882Biosphere® screw cap, neutralSarstedt Aktiengesellschaft & Co.KGKDT2025-07-25
G669CNBOX1CST0Crow's Nest Biopsy Catchment SystemCorramedical Inc.KDT2025-07-09
G669CNBOX4CST1Crow's Nest Biopsy Catchment SystemCorramedical Inc.KDT2025-07-09
20809160466947Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
0406691600597925 ml tube 90x 25Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-28
04066916018405urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
04038917923460Srew cap, pinkSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917923521Srew cap, orangeSarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917994590SC MTube 0,5 ml Sarstedt Aktiengesellschaft & Co.KGKDT2024-11-28
04038917242578Tube 50ml, 114x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-16
04038917189705Tube 50ml, 115x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-07
04038917408578Tube 5ml, 75x13mmSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917994248Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04038917996570Micro tube 0.5ml, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
04066916005399Urine cup NFT 100ml temp. labSarstedt Aktiengesellschaft & Co.KGKDT2024-07-22
04038917410021Tube 39 x 13 Sarstedt Aktiengesellschaft & Co.KGKDT2024-05-22
10850054552041US Paramed Collection Oral Fluid KitQuest DiagnosticsKDT2024-05-01
0403891736996110ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
040389179925418,5 ml Urine Monovette Sarstedt Aktiengesellschaft & Co.KGKDT2024-04-26