Identity
- Trade Name
- Gongdong FDA UDI
- Generic Name
- Urine transfer IVD, non-sterile FDA UDI
- Device Name
- 6.5oz clear beaker + 2 x 30ML Siamese tubes + biobags with absorbent cotton FDA UDI
- Model / Reference
- Q128 FDA UDI
- Description
- 6.5oz clear beaker + 2 x 30ML Siamese tubes + biobags with absorbent cotton FDA UDI
Identifiers
- Primary DI / UDI-DI
- 86947462401610 FDA UDI
- FDA Product Code
- NNI FDA UDI
- GMDN Term
- Urine transfer IVD, non-sterile 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Urine transfer IVD, non-sterile
Gongdong by Zhejiang Gongdong Medical Technology Co., Ltd., — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine transfer IVD, non-sterile.
- UriCap Base kit box of 5 — TILLA CARE LTD · Class I
- VACUETTE — Greiner Bio-One GmbH · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Urine Transfer Straw — Sarstedt Aktiengesellschaft & Co.KG · Class I
- UriCap Female 1 Set SX — TILLA CARE LTD · Class I
- Extension Tube — TILLA CARE LTD · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Vacuette — Greiner Bio-One GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Gongdong Medical Technology Co., Ltd.,
Sources (1)
- FDA UDI 6eac7a17-5b04-4de8-9093-f859b99b3d4f 33 fields · synced May 30, 2026