FDA.reportPublic FDA data

T-Cup

Primary DI
10816862024262
Brand
T-Cup
Company
WONDFO USA CO., LTD.
Model
TDOA-SVTV
Device description
T-Cup with Vaccu Lid,3 SVT strips (CR/pH/S.G.) and Temp Strip
Published
2024-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816862024262PackageGS14In Commercial Distribution
00816862024265PrimaryGS10
00816862024272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202426210816862024262
00816862024265008168620242658168620242650816862024265
00816862024272008168620242728168620242720816862024272

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-468-2199wondfo@wondfousa.com

Regulatory Flags#

DUNS number
849098897
Device count
25
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
00810174470369HORMONElife™DW52-S-SQ-6BX-H2026-06-26
00810174470543HORMONElife™DW1-S25-15BX-H2026-06-26
00810174471229Prime Screen®DCDOA-L964-5BX-A2026-06-26
00810174471410Prime Screen®DTDOA-274-1BX-A2026-06-26
00816862027303WELLlife™WCOV-CON-52026-06-01
00816862028416WELLlife™WCOVID-POC-252026-06-01
00816862028294SAFElife™CDOA-L11135A32026-05-15
00816862028324WELLlife™ WFOB-OTC-2BX2026-05-15
00816862028348SAFElife™CDOA-6135F2026-05-15
00816862028362SAFElife™TDOA-6135F2026-05-15
00816862028393SAFElife™WEDDP-1142026-05-15
00816862028249SAFElife™CDOA-12135NT2026-01-15
00816862028270HORMONElife™H1-S-20BG2026-01-15
00816862027723HORMONElife™H1-S-E10-25BX-CLIA2026-01-15
00816862028164SAFElife™CDOA-12135NT2026-01-15
00816862028263HORMONElife™H1-S-20BG2026-01-15
00816862028027SAFElife™CDOA-L111452025-12-15
00816862028089SAFElife™CDOA-L11135A32025-12-15
00816862028102HORMONElife™H2-S-50BG2025-12-15
00816862028157HORMONElife™H1-C-25BX-CLIA2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817518026275MarketLab, Inc.MARKETLAB INC.NNI2026-07-16
07333066021812EliA Stool Extraction Kit plusPhadia ABNNI2026-06-25
00827989008106Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-10
00827989008090Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2026-06-09
10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500581LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
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10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
00840117337374LabChoice Pet Cell Bottle, 500 mLDynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mLDynarex CorporationNNI2025-06-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28