OnGuard2 Chemfort Bag Adaptor CP
The FDA filing lists the Bag Adaptor Chemfort Port (BACP) as one of four devices in the OnGuard2 Chemfort Closed Administration system. The BACP is available separately and connects between…
The FDA filing lists the Bag Adaptor Chemfort Port (BACP) as one of four devices in the OnGuard2 Chemfort Closed Administration system. The BACP is available separately and connects between an infusion container and a primary set.
The BACP’s distal Chemfort port provides both the drug-transfer path into an IV bag and the infusion outflow path. The filing says a CADM set connects to that port for administration, creating a closed system.
Listed Item
For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration (CADM) The Bag Adaptor CP connect to Syringe Adaptor / Syringe Adaptor Lock and to CADM sets
Component Distinction
The submission distinguishes the BACP from the predicate Bag Adaptor SP: the BACP uses its distal Chemfort port for both transfer and outflow, while the predicate has separate paths.
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) | K210707 |
| Record published | 2021-10-17 |
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 |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 412166 | 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 |
| 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
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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.