| Primary Device ID | B96412VFM4L02 |
| NIH Device Record Key | 704dc1b0-9ce5-4f7c-b9d8-77bca6b40fe4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smithworks Medical Inc. |
| Version Model Number | 12VFM4L02 |
| Company DUNS | 009796074 |
| Company Name | Smithworks, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B96412VFM4L02 [Primary] |
| LGZ | Warmer, Thermal, Infusion Fluid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-16 |
| Device Publish Date | 2024-04-08 |
| B96412VFM4L02 - Smithworks Medical Inc. | 2024-04-16FloorMount IV Fluid Warmer |
| B96412VFM4L02 - Smithworks Medical Inc. | 2024-04-16 FloorMount IV Fluid Warmer |
| B96412VPK2L02 - Smithworks Medical, Inc | 2024-04-16 C-Mount IV fluid Warmer |
| B96412VPK3L12 - Smithworks Medical, Inc. | 2024-04-16 PAK2-P IV fluid warmer |
| B96412VSS3L02 - Smithworks Medical, Inc. | 2024-04-16 Soft Sack IV fluid warmer |
| B964TSPI05 - Smithworks Medical, Inc. | 2024-04-16 The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv fluid warmers as a thermal main |