| Primary Device ID | 00850003277042 |
| NIH Device Record Key | 3a6241de-2449-410e-8c23-8e4818384ed1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HypothermX LG Intravenous Fluid and Blood Warmer |
| Version Model Number | FA100004 |
| Company DUNS | 958227451 |
| Company Name | EMIT CORPORATION |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003277042 [Primary] |
| GS1 | 00850003277059 [Package] Package: 5 Pack [5 Units] In Commercial Distribution |
| GS1 | 00850003277066 [Package] Package: Single Pack [1 Units] In Commercial Distribution |
| GS1 | 00850003277073 [Package] Package: 2 Pack [2 Units] In Commercial Distribution |
| GS1 | 00850003277080 [Package] Package: 3 Pack [3 Units] In Commercial Distribution |
| GS1 | 00850003277097 [Package] Package: 4 Pack [4 Units] In Commercial Distribution |
| LGZ | Warmer, Thermal, Infusion Fluid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-26 |
| Device Publish Date | 2018-10-25 |
| 00850003277035 - HypothermX HX100 Intravenous Fluid and Blood Warmer | 2018-11-26 |
| 00850003277042 - HypothermX LG Intravenous Fluid and Blood Warmer | 2018-11-26 |
| 00850003277042 - HypothermX LG Intravenous Fluid and Blood Warmer | 2018-11-26 |