Equashield
Luer Lock Adaptor Spinlock
1manufacturer
83catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Equashield Medical Ltd, Israel |
|---|---|
| FDA product code | ONB |
| Device type | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2016-05-16 |
| Record revised | 2023-07-13 (version 4) |
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, serial number |
| Packaging | Pack of 120, pack of 240, pack of 480, pack of 60, pack of 40, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Equashield Syringe Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Accesories | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Male Luer Lock Connector | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Spike Adaptor 180 | In distribution | |
| Equashield Male Luer Lock Connector | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Spike Adaptor W 180 | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Protective Plug | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Male Luer Lock Connector | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Luer Lock Adaptor Spinlock | In distribution | |
| Equashield Accesories | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Female Luer Lock Connector 180 | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Accesories | In distribution | |
| Equashield Male Luer Lock Connector | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Luer Lock Adaptor | In distribution | |
| Equashield Male Luer Lock Connector | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Female Luer Lock Connector | In distribution | |
| Equashield Protective Plug | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Accesories | In distribution | |
| Equashield Protective Plug | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Female Luer Lock Connector | In distribution | |
| Equashield Protective Plug | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Accessories | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Female Luer Lock Connector | In distribution | |
| Luer Lock Adaptor Swivel | In distribution | |
| Equashield Accessories | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Female Luer Lock Connector | In distribution | |
| Equashield Female Luer Lock Connector | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Accessories | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Accessories | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Female Luer Lock Connector | In distribution | |
| Equashield Accesories | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Spike Adaptor W | In distribution | |
| Equashield Spike Adaptor 1 | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Syringe Unit | In distribution | |
| Equashield Vial Adaptor Unit | In distribution | |
| Equashield Protective Plug | In distribution | |
| Equashield Reconstitution Set | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 255 |
| 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 |
| Tevadaptor Catheter Adaptor | Simplivia Healthcare Ltd. | 1 |
Showing 12 of 60. All products under Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221513 | 2023-02-17 |
| K170706 | 2017-07-03 |
| K150219 | 2015-11-05 |
| K132899 | 2014-05-13 |
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.