FDA UDI
In Commercial Distribution
🇺🇸 United States
T-Cup
DI: 00816862024265
·
Model: TDOA-SVTV
·
WONDFO USA CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- T-Cup
- Primary DI
- 00816862024265
- Version / Model
- TDOA-SVTV
- Company Name
- WONDFO USA CO., LTD.
- Labeler DUNS
- 849098897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-05-23
- Public Version
- 1
- Public Version Date
- 2024-05-31
- Public Version Status
- New
- Public Device Record Key
- 08db0b3a-c64d-4bf9-a17b-b37e9e58f0c4
Device Description
T-Cup with Vaccu Lid,3 SVT strips (CR/pH/S.G.) and Temp Strip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNI | Container, Specimen, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63232 | General specimen container IVD, additive/medium | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816862024262 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 00816862024265 | GS1 | ||||
| Unit of Use | 00816862024272 | GS1 |
Customer Contacts
- Phone
- 630-468-2199
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius