Identity
- Trade Name
- BD Vacutainer® C&S Cup Kit FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, preservative FDA UDI
- Device Name
- KIT URIN CUP 13X75 4.0 C&S GR FDA UDI
- Model / Reference
- 364954 FDA UDI
- Description
- KIT URIN CUP 13X75 4.0 C&S GR FDA UDI
Identifiers
- Catalog Number
- 364954 FDA UDI
- Primary DI / UDI-DI
- 50382903649544 FDA UDI
- 510(k) Number
- K024240 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evacuated urine specimen container IVD, preservative
BD Vacutainer® C&S Cup Kit by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated urine specimen container IVD, preservative.
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- Vacuette — Greiner Bio-One GmbH · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Vacuette — Greiner Bio-One GmbH · Class I
- Gongdong — Zhejiang Gongdong Medical Technology Co., Ltd., · Class I
- Vacuette — Greiner Bio-One GmbH · Class I
Cleared under the same submission
K024240 also covers:
- BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube — BECTON DICKINSON AND COMPANY
- BD Vacutainer® C&S Preservative Urine Tube — BECTON DICKINSON AND COMPANY
- BD Vacutainer® C&S Transfer Straw Kit — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Urine Complete Cup Kit — BECTON DICKINSON AND COMPANY
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI 7c45b474-6e55-4444-959a-775377ceb58b 36 fields · synced May 30, 2026