OnGuard2 Syringe Adaptor Sterile Replacement Cap
Sterile Replacement Cap for OnGuard2 Syringe Adaptor or Syringe Adaptor Lock
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 | 2022-08-28 |
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 400 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 412177 | 100 | 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 |
| 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 |
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.