Pro-Flo™
Catheter 010315 PF 10PK 7F 100 IMA
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | FHM |
| Device type | Apparatus, Suturing, Stomach And Intestinal |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-06-13 |
| Record revised | 2022-09-22 (version 4) |
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 |
| Storage | Special storage condition: Store catheters in a cool, dry area. |
| Packaging | Pack of 10 |
| Sizes | Lumen/inner diameter 1.55 mm; length 100 cm; catheter gauge 7 Fr |
| Distribution end date | 2019-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010315 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
Same Product Code
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| GIA Premium | Covidien LP | 3 |
| TA Premium | Covidien LP | 3 |
| Para-Pak Clean | Meridian Bioscience, Inc. | 1 |
| TA 90 BN | Covidien LP | 1 |
| Premium Multifire TA | Covidien LP | 1 |
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.