Identity
- Trade Name
- Gongdong FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, preservative FDA UDI
- Device Name
- Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 10ml FDA UDI
- Model / Reference
- GD100UB FDA UDI
- Description
- Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 10ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16947462492817 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- Evacuated urine specimen container IVD, preservative FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evacuated urine specimen container IVD, preservative
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 Evacuated urine specimen container IVD, preservative.
- V-Monovette®Urine 10ml bo.acid — Sarstedt Aktiengesellschaft & Co.KG · Class I
- BD Vacutainer® Urinalysis Transfer Straw Kit — BECTON DICKINSON AND COMPANY · Class I
- BD Vacutainer® C&S Cup Kit — BECTON DICKINSON AND COMPANY · Class I
- V-Monovette® Urine 4ml bo.acid — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Vacuette — Greiner Bio-One GmbH · Class I
- BD Vacutainer® Urine Complete Cup Kit — BECTON DICKINSON AND COMPANY · Class I
- BD Vacutainer® C&S Boric Acid Kit — BECTON DICKINSON AND COMPANY · Class I
- BD Vacutainer® C&S Preservative Urine Tube — BECTON DICKINSON AND COMPANY · 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 0f13fab7-4d8d-47f7-8db1-dbbd5495078c 33 fields · synced May 30, 2026