BD PhaSeal Optima
BD Phaseal™ Optima Connecting Set (C83-O)
1manufacturer
11catalogue numbers in this listing
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 | BD Switzerland Sàrl |
|---|---|
| FDA product code | ONB |
| Device type | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K250059 |
| Record published | 2025-12-19 |
| Record revised | 2025-07-17 (version 4) |
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: Room Temperature |
| Packaging | Case of 4, case of 250, shelfpack of 50, pack or inner pack of 50, box of 50, shelfpack of 25 |
| Sizes | Lumen/inner diameter 13 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 515628 | In distribution | ||
| 515060 | In distribution | ||
| 515070 | In distribution | ||
| 515064 | In distribution | ||
| 515057 | In distribution | ||
| 515629 | In distribution | ||
| 515053 | 250 | In distribution | |
| 515052 | In distribution | ||
| 515078 | In distribution | ||
| 515062 | Lumen/Inner Diameter 13 mm | In distribution | |
| 515079 | 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 |
| 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 |
| Tevadaptor Catheter Adaptor | 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.