Surecan Safety II
Surecan™ Safety II Port Access Needle Set with Caresite® Y Injection Site 22G x 0.8 in. (20mm)
4manufacturers in China registered for this device type
26catalogue 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 | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | PTI |
| Device type | Non-Coring (Huber) Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-12-07 |
| Record revised | 2020-03-11 (version 11) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 5 |
| Distribution end date | 2024-09-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4447010-02 | 20 | In distribution | |
| 4447058-02 | 20 | In distribution | |
| 4447050-02 | 20 | In distribution | |
| 4447008-02 | Length of cannula (metric) : 32.000 MM | 20 | In distribution |
| 4447009-02 | Length of cannula (metric) : 38.000 MM | 20 | In distribution |
| 4447059-02 | 20 | In distribution | |
| 4447013-02 | Length of cannula (metric) : 32.000 MM | 20 | In distribution |
| 4447004-02 | Gauge (cannula) : 19 | 20 | In distribution |
| 4447044-02 | Length of cannula (metric) : 12.000 MM | 20 | In distribution |
| 4447006-02 | Length of cannula (metric) : 20.000 MM | 20 | In distribution |
| 4447045-02 | 20 | In distribution | |
| 4447012-02 | Length of cannula (metric) : 25.000 MM | 20 | In distribution |
| 4447002-02 | Length of cannula (metric) : 25.000 MM | 20 | In distribution |
| 4447056-02 | Length of cannula (metric) : 25.000 MM | 20 | In distribution |
| 4447055-02 | Length of cannula (metric) : 20.000 MM | 20 | In distribution |
| 4447005-02 | 20 | In distribution | |
| 4447051-02 | Length of cannula (metric) : 20.000 MM | 20 | In distribution |
| 4447046-02 | Length of cannula (metric) : 20.000 MM | 20 | In distribution |
| 4447001-02 | Length of cannula (metric) : 20.000 MM | 20 | In distribution |
| 4447043-02 | 20 | In distribution | |
| 4447052-02 | Length of cannula (metric) : 25.000 MM | 20 | In distribution |
| 4447047-02 | Length of cannula (metric) : 25.000 MM | 20 | In distribution |
| 4447011-02 | Length of cannula (metric) : 20.000 MM | 20 | In distribution |
| 4447000-02 | 20 | In distribution | |
| 4447007-02 | Length of cannula (metric) : 25.000 MM | 20 | Withdrawn |
| 4447007-02 | Gauge (cannula) : 20 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K170897 | 2017-11-03 |
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.