MF Safecath
MF Safecath is a disposable intravascular catheter for short-term vascular access. Its polyurethane catheter tube and stainless steel introducer needle provide the assembly used for…
MF Safecath is a disposable intravascular catheter for short-term vascular access. Its polyurethane catheter tube and stainless steel introducer needle provide the assembly used for intravenous fluids, blood sampling or pressure monitoring.
Withdrawing the needle automatically activates a passive shield. The shield advances over the inner cannula and covers its full length, including the tip, as the needle separates from the catheter.
Flashback and Sizes
A groove on the cannula surface allows blood return to be observed as flashback when the assembly is in the vessel. The range includes 16, 18, 20, 22 and 24 gauge catheters in different lengths.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Medifirst Co., Ltd., South Korea |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Manufacturer |
| 510(k) | K192230 |
| Record published | 2020-08-10 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 200 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SS207 | 50 | In distribution | |
| SC109 | 50 | In distribution | |
| SC104 | 50 | In distribution | |
| SS205 | 50 | In distribution | |
| SC101 | 50 | In distribution | |
| SC106 | 50 | In distribution | |
| SS203 | 50 | In distribution | |
| SC103 | 50 | In distribution | |
| SS201 | 50 | In distribution | |
| SC108 | 50 | In distribution | |
| SS206 | 50 | In distribution | |
| SC102 | 50 | In distribution | |
| SS204 | 50 | In distribution | |
| SS202 | 50 | In distribution | |
| SC110 | 50 | In distribution | |
| SS208 | 50 | In distribution | |
| SC105 | 50 | In distribution | |
| SC107 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192230 | 2020-04-23 |
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.