SafeStep
12 catalogue numbers from CPA00043, listed by Bard Access Systems, Inc., United States, under Non-Coring (Huber) Needle. 4 manufacturers in China are registered for this product code.
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 | 2018-01-17 |
| Record revised | 2019-10-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5 |
| Sizes | Needle gauge 19 to 22 G; length 0.75 to 1 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPA00043 | Needle Gauge 20 G | In distribution |
| CPA00044 | Length 0.75 in | In distribution |
| CPA00042A | Needle Gauge 20 G | In distribution |
| CPA00076 | Length 0.75 in | In distribution |
| CPA00040B | Needle Gauge 19 G | In distribution |
| CPA00043A | Length 1 in | In distribution |
| CPA00049 | Needle Gauge 20 G | In distribution |
| CPA00040 | Needle Gauge 19 G | In distribution |
| CPA00019B | Needle Gauge 20 G | In distribution |
| CPA00042 | Length 0.75 in | In distribution |
| CPA00044A | Needle Gauge 22 G | In distribution |
| CPA00040A | Length 1 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 |
| AllPoints Port Access System PowerLoc Max | 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 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2020-06-19 | Class II | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material | 5,296,132 total | 2022-07-29 |
| Becton, Dickinson & Co. | UDI-DI | 2020-06-19 | Class II | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material | 5,296,132 total | 2022-07-29 |
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.