Identity
- Trade Name
- BD PhaSeal Optima FDA UDI
- Generic Name
- Vial/bottle adaptor, hermetic FDA UDI
- Device Name
- PROTECTOR P13-O FDA UDI
- Model / Reference
- 515060 FDA UDI
- Description
- PROTECTOR P13-O FDA UDI
Identifiers
- Catalog Number
- 515060 FDA UDI
- Primary DI / UDI-DI
- 00382905150609 FDA UDI
- FDA Product Code
- ONB FDA UDI
- GMDN Term
- Vial/bottle adaptor, hermetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
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
Yes
FDA UDI
Category: Vial/bottle adaptor, hermetic
BD PhaSeal Optima by BD Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- BD Switzerland Sàrl
Sources (1)
- FDA UDI 9d8d50c1-3059-4b0c-a593-82cccc2066dc 35 fields · synced May 30, 2026