Para-Pak Clean
Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites
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 | Meridian Bioscience, Inc., United States |
|---|---|
| FDA product code | FHM |
| Device type | Apparatus, Suturing, Stomach And Intestinal |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9003-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GIA Premium | Covidien LP | 3 |
| TA Premium | Covidien LP | 3 |
| TA 90 BN | Covidien LP | 1 |
| Premium Multifire TA | Covidien LP | 1 |
| Pro-Flo™ | Medtronic, Inc. | 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.