| Primary Device ID | 08719992086016 |
| NIH Device Record Key | 9c46127d-59c2-41bd-b623-81d5034e0834 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lavage Procedure Kit |
| Version Model Number | 1 |
| Company DUNS | 490348632 |
| Company Name | Eight Medical International B.V. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 08719992086016 [Primary] |
| 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 | 2020-04-20 |
| Device Publish Date | 2020-04-10 |
| 08719992086009 - Recirculator | 2020-04-20 The Recirculator 8.0 is comprised of two components: a portable control console and a single use disposable. The Console consi |
| 08719992086016 - Lavage Procedure Kit | 2020-04-20The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile. |
| 08719992086016 - Lavage Procedure Kit | 2020-04-20 The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The |