Pall® Total Nutrient Admixture Filter
1.2 micron Total Nutrient Admixture Filter with Non-Phthalate Fluid Pathway
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | Global Life Sciences Solutions USA LLC, United States |
|---|---|
| FDA product code | FPB |
| Device type | Filter, Infusion Line |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K905794 |
| Record published | 2016-06-01 |
| Record revised | 2026-02-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 40 |
| Sizes | Pore size 1.2 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TNA1 | Pore Size 1.2 µm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medex | ICU Medical, Inc | 44 |
| Vygon | Vygon Corp. | 22 |
| Pall Posidyne® ELD Filter | Global Life Sciences Solutions USA LLC | 5 |
| GRI-BAG | Laboratorios Grifols SA | 3 |
| Hemo-Nate | Utah Medical Products, Inc. | 3 |
| Filter, Infusion Line | Baxter Healthcare Corporation | 3 |
| Interlink | Baxter Healthcare Corporation | 3 |
| Pall Posidyne® NEO Filter | Global Life Sciences Solutions USA LLC | 2 |
| Hemo-TAP | Utah Medical Products, Inc. | 2 |
| Pall Supor® AEF Filter | Pall International Sàrl | 2 |
| Spectrum, Inc. | Spectrum Medical Ltd | 2 |
| WalkMed® | WalkMed Technologies, LLC | 2 |
Showing 12 of 21. All products under Filter, Infusion Line
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261403 | 2026-08-31 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Pall Life Sciences Puerto Rico, LLC | 510(k) number | 2011-06-15 | Not classified | Labeling mix-ups | Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures. | 15,575 units | 2013-01-10 |
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.