PhaSeal Optima
PhaSeal Optima Protector (P28-O)
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
Record
| Listed by | Becton Dickinson PEN Limited |
|---|---|
| FDA product code | ONB |
| Device type | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Record published | 2022-07-29 |
| Record revised | 2025-11-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
| Packaging | Pack or inner pack of 25, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 515063 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 255 |
| Equashield | Equashield Medical Ltd | 83 |
| BD PhaSeal | BD Switzerland Sàrl | 23 |
| Halo | J & J Solutions, Inc. | 14 |
| ProSeal Cstd | Epic International (Thailand) Co., Ltd. | 12 |
| BD PhaSeal Optima | BD Switzerland Sàrl | 11 |
| Equashield Cstd | Equashield Medical Ltd | 6 |
| Luer Lock Adaptor 2 Swivel A | Equashield Medical Ltd | 1 |
| ICU Medical, Inc. | ICU Medical, Inc | 1 |
| OnGuard®2 Cstd Luer Lock Adaptor | Simplivia Healthcare Ltd. | 1 |
| OnGuard2 Syringe Adaptor, 5 Units | Simplivia Healthcare Ltd. | 1 |
| OnGuard 2 Cstd Bag Adaptor LL with Ultrasite | Simplivia Healthcare Ltd. | 1 |
Showing 12 of 60. All products under Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.