OnGuard®2 Cstd Luer Lock Adaptor
OnGuard®2 CSTD Luer Lock Adaptor A Chemfort CSTD Product
1manufacturer
1catalogue number
6510(k) clearances naming this product code
1recall
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 | Simplivia Healthcare 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 | Manufacturer |
| 510(k) | K192866 |
| Record published | 2020-07-12 |
| Record revised | 2020-09-25 (version 2) |
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 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 412160 | 50 | 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 |
| 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 |
|---|---|
| K253033 | 2025-10-21 |
| K251411 | 2025-08-05 |
| K231286 | 2023-08-02 |
| K210707 | 2021-09-23 |
| K201142 | 2021-02-25 |
| K192866 | 2020-05-07 |
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 |
|---|---|---|---|---|---|---|
| Simplivia Healthcare Ltd. | 510(k) number | 2022-03-08 | Class II | Equipment maintenance | Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. | 293,520 |
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.