Identity
- Trade Name
- Ditek Urine Collection Cup FDA UDI
- Generic Name
- 24-hour urine specimen container IVD, no additive FDA UDI
- Device Name
- Urine Cup 8oz with Lid FDA UDI
- Model / Reference
- CP10221 FDA UDI
- Description
- Urine Cup 8oz with Lid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10860009784892 FDA UDI
- FDA Product Code
- NNI FDA UDI
- GMDN Term
- 24-hour urine specimen container IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: 24-hour urine specimen container IVD, no additive
Ditek Urine Collection Cup by Medzah Industries — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 24-hour urine specimen container IVD, no additive.
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- LabChoice 24-Hour Urine Collection Container, 3000 mL — Dynarex Corp. · Class I
- Medegen Medical Products, LLC — Medegen Medical Products · Class II
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medzah Industries
Sources (1)
- FDA UDI 3cd2da74-b584-4ce5-a37b-1d7234bce5d3 34 fields · synced May 29, 2026