| Primary Device ID | 35034480000393 |
| NIH Device Record Key | 80a04a32-7ae3-46d7-9680-72ff142a666d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pall LeukoGuard LG |
| Version Model Number | LG6 |
| Catalog Number | LG6 |
| Company DUNS | 485050483 |
| Company Name | Pall International Sàrl |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)645-6578 |
| EURegulatory@europe.pall.com |
| Pore Size | 40 Micrometer |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05034480000392 [Primary] |
| GS1 | 35034480000393 [Package] Contains: 05034480000392 Package: case [6 Units] In Commercial Distribution |
| DTM | Filter, blood, cardiopulmonary bypass, arterial line |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[35034480000393]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-21 |
| 35034480000409 | Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with By |
| 35034480000393 | Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service |