AllPoints Port Access System PowerLoc Max
AllPoints Port Access System PowerLoc Max 20G x 0.75 inch with Y-Site + GuardIVa
4manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | PTI |
| Device type | Non-Coring (Huber) Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-09-21 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10 |
| Sizes | Length 0.75 to 1 in; needle gauge 20 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AN132010B | Length 1.0 in | In distribution |
| AN142010M | Length 1.0 in | In distribution |
| AN132010 | Length 1.0 in | In distribution |
| AN142075B | Needle Gauge 20 G | In distribution |
| AN132075M | Needle Gauge 20 G | In distribution |
| AN132010G | Needle Gauge 20 G | In distribution |
| AN142075G | Needle Gauge 20 G | In distribution |
| AN142010B | Needle Gauge 20 G | In distribution |
| AN132010M | Needle Gauge 20 G | In distribution |
| AN132075G | Needle Gauge 20 G | In distribution |
| AN142075M | Length 0.75 in | In distribution |
| AN132075B | Length 0.75 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surecan Safety II | B. Braun Medical Inc. | 26 |
| Infusion Safety Products, Inc. | Infusion Safety Products, Inc. | 26 |
| Medline | Medline Industries, Inc. | 18 |
| K-Shield Advantage Port Access Infusion SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | 12 |
| SafeStep | Bard Access Systems, Inc. | 12 |
| Port Access | Bard Access Systems, Inc. | 10 |
| AllPoints Port Access System SafeStep | Bard Access Systems, Inc. | 9 |
| Intera | Intera Oncology | 5 |
| PowerLoc Max | Bard Access Systems, Inc. | 3 |
| Safe Step | Bard Access Systems, Inc. | 2 |
| 20G X 3/4″ PRO-Lock CT Safety Infusion SET20G X 3/4″ PRO-Lock CT Safety Infusion | Medical Components Inc | 1 |
| 20G X 5/8″ PRO-Lock CT Safety Infusion SET20G X 5/8″ PRO-Lock CT Safety Infusion | Medical Components Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241353 | 2024-11-27 |
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.