BD PhaSeal
Cap For Injector Membrane (M50)
1manufacturer
23catalogue 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 |
| Record published | 2023-05-10 |
| Record revised | 2025-07-04 (version 8) |
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 | Case of 4, pack or inner pack of 50, shelfpack of 50, case of 250, box of 50, pack or inner pack of 25 |
| Sizes | Outer diameter 21 to 32 mm; lumen/inner diameter 20 to 21 mm; total volume 0.09 to 0.1 ml |
| Distribution end date | 2025-10-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 515406 | In distribution | ||
| 515103 | Lumen/Inner Diameter 21 mm | In distribution | |
| 515105 | Diameter = 21 millimetre (mm) | In distribution | |
| 515404 | In distribution | ||
| 515307 | In distribution | ||
| 515001 | In distribution | ||
| 515065 | Lumen/Inner Diameter 20 mm | In distribution | |
| 515102 | Diameter = 21 millimetre (mm) | In distribution | |
| 515304 | In distribution | ||
| 515104 | Diameter = 28 millimetre (mm) | In distribution | |
| 515005 | 250 | In distribution | |
| 515106 | In distribution | ||
| 515056 | In distribution | ||
| 515004 | In distribution | ||
| 515306 | In distribution | ||
| 515200 | Total Volume 0.09 ml | In distribution | |
| 515100 | In distribution | ||
| 515305 | In distribution | ||
| 515117 | Diameter = 21 millimetre (mm) | In distribution | |
| 515107 | Diameter = 32 millimetre (mm) | In distribution | |
| 515003 | In distribution | ||
| 515202 | Total Volume 0.1 ml | In distribution | |
| 515302 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 255 |
| Equashield | Equashield Medical Ltd | 83 |
| 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 |
| Tevadaptor Catheter Adaptor | Simplivia Healthcare Ltd. | 1 |
Showing 12 of 60. All products under Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2022-07-18 | Class II | Employee error | Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product. | 9,340 units |
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.