Halo
Halo 20mm Closed Vial Adaptor
1manufacturer
14catalogue 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 | J & J Solutions, Inc. |
|---|---|
| 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) | K150486 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CSA100 | 240 | In distribution | |
| CLA100 | 100 | In distribution | |
| CVC130 | 100 | In distribution | |
| CSA100 | 60 | In distribution | |
| CVC130 | 200 | In distribution | |
| CVA200 | 18 | In distribution | |
| CVA130 | 72 | In distribution | |
| CLA100 | 400 | In distribution | |
| CBA100 | 32 | In distribution | |
| CVA280 | 18 | In distribution | |
| CVA280 | 72 | In distribution | |
| CVA200 | 72 | In distribution | |
| CBA100 | 128 | In distribution | |
| CVA130 | 18 | 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 |
| 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 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| J&J Solutions, Inc. DBA Corvida Medical | 510(k) number | 2016-11-22 | Class II | Under Investigation by firm | Product malfunction: Needle does not retract. | 5520 units | 2018-11-09 |
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.