Identity
- Trade Name
- BD PhaSeal™ Optima Infusion Clamp M25-O FDA UDI
- Generic Name
- Intravenous line closed infusion system clamp FDA UDI
- Device Name
- M25-O Infusion Clamp FDA UDI
- Model / Reference
- 515085 FDA UDI
- Description
- M25-O Infusion Clamp FDA UDI
Identifiers
- Catalog Number
- 515085 FDA UDI
- Primary DI / UDI-DI
- 00382905150852 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Intravenous line closed infusion system clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravenous line closed infusion system clamp
BD PhaSeal™ Optima Infusion Clamp M25-O by Becton Dickinson Pen Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous line closed infusion system clamp.
- BD PhaSeal — BECTON DICKINSON PEN LIMITED · 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
- Becton Dickinson Pen Limited
Sources (1)
- FDA UDI f1cd279d-8f34-45f7-b38f-31aaca97f4b5 35 fields · synced Jun 6, 2026