Para-Pak Zn-PVA / 10% Formalin / Clean
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed…
Para-Pak systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by those not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
Who Else Makes It
Concentrated in Jiangsu (29), Zhejiang (24), Guangdong (8). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 79. All 79 manufacturers in China registered for Container, Specimen, Sterile
Record
| Listed by | Meridian Bioscience, Inc., United States |
|---|---|
| FDA product code | FMH |
| Device type | Container, Specimen, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2020-12-10 |
| Record revised | 2023-10-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 331084 | In distribution | |
| 331084 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 103 |
| Corning® | Corning Incorporated | 49 |
| Cardinal Health | Cardinal Health 200, LLC | 42 |
| Medline | Medline Industries, Inc. | 41 |
| Bioseal Inc. | Bioseal | 37 |
| Centurion | Centurion Medical Products Corporation | 29 |
| Globe Scientific | Globe Scientific, LLC | 29 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 27 |
| Sterile Specimen Container | Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. | 20 |
| Vacuette | Greiner BIO-ONE Gmbh | 19 |
| Precision | Cardinal Health | 15 |
| Dover | Cardinal Health | 14 |
Showing 12 of 182. All products under Container, Specimen, Sterile
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-10-19 | Class II | Process control | Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen. | 571 Cases |
| 2023-10-19 | Class II | Process control | Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. | 38 Cases |
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.