Identity
- Trade Name
- MRVLS FDA UDI
- Generic Name
- Stopcock FDA UDI
- Device Name
- MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS) FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- MRVLS 4 WAY RAD Elcam Minimal Residual Volume Luer activated swabable stopcock (MRVLS) FDA UDI
Identifiers
- Catalog Number
- 572808 FDA UDI
- Primary DI / UDI-DI
- 07290102590018 FDA UDI
- 510(k) Number
- K060231 FDA UDI
- FDA Product Code
- FMG FDA UDI
- GMDN Term
- Stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Pressure — 200 KiloPascal FDA UDI
Mrvls by Elecam Medical Agricultural Cooperative Society Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060231 also covers:
- CSTP LB 2V GXL BLS — Elecam Medical Agricultural Cooperative Society Ltd.
- CSTP LB1V GXL BLS RAD — Elecam Medical Agricultural Cooperative Society Ltd.
- MRVLS LB 2V GXL BLS — Elecam Medical Agricultural Cooperative Society Ltd.
- MRVLS LB1V GXL BLS RAD — Elecam Medical Agricultural Cooperative Society Ltd.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Elecam Medical Agricultural Cooperative Society Ltd.
Sources (1)
- FDA UDI ad23544e-2c78-4219-af8b-1ca28c514765 39 fields · synced May 30, 2026