Infusion Safety Products, Inc.
The ISP Safety Huber Needle Infusion Set accesses a surgically implanted vascular port to administer fluids or withdraw blood. It uses a right-angled, non-coring Huber needle with attached…
The ISP Safety Huber Needle Infusion Set accesses a surgically implanted vascular port to administer fluids or withdraw blood. It uses a right-angled, non-coring Huber needle with attached tubing and connection components.
A safety wing holds the needle during access and encloses it during removal to help prevent needlestick injury. The set is available in different needle gauges and lengths, with straight tubing or Y-port configurations.
Listed Item
20ga x 1.50″ RA, Non-Coring Safety Huber Needle Infusion Set with 8.5″ tubing and a “Y” port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume.35cc
Materials and Supply
The tubing is non-DEHP PVC, and the device is latex-free and lipid-resistant. It is supplied sterile following ethylene-oxide processing. The stated CT injection limit is 300 psi, with maximum flow approximately 5 mL per second.
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 | Infusion Safety Products, Inc., United States |
|---|---|
| FDA product code | PTI |
| Device type | Non-Coring (Huber) Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K170881 |
| Record published | 2018-07-20 |
| Record revised | 2020-02-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25 |
| Distribution end date | 2020-02-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ISP2075 | In distribution | |
| ISP205 | In distribution | |
| ISP2015Y | In distribution | |
| ISP191 | In distribution | |
| ISP2015 | In distribution | |
| ISP2215Y | In distribution | |
| ISP2275Y | In distribution | |
| ISP1915Y | In distribution | |
| ISP225Y | In distribution | |
| ISP2215 | In distribution | |
| ISP195 | In distribution | |
| ISP191Y | In distribution | |
| ISP1915 | In distribution | |
| ISP2075Y | In distribution | |
| ISP201 | In distribution | |
| ISP225 | In distribution | |
| ISP221Y | In distribution | |
| ISP1975Y | In distribution | |
| ISP1975 | In distribution | |
| ISP205Y | In distribution | |
| ISP2275 | In distribution | |
| ISP201Y | In distribution | |
| ISP195Y | In distribution | |
| ISP221 | In distribution | |
| ISP195 | Withdrawn | |
| ISP1975 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surecan Safety II | B. Braun Medical 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 |
|---|---|
| K170881 | 2017-12-14 |
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.