| Primary Device ID | 07350016061704 |
| NIH Device Record Key | 904ca84a-f19d-43c9-8fc4-c3dac4cd5b94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfortline HI LO 230V, 50mm drain-LONG, Reverse installation |
| Version Model Number | 05194009 |
| Company DUNS | 354437485 |
| Company Name | Tr Equipment AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350016061704 [Primary] |
| KTC | Bath, Sitz, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-20 |
| Device Publish Date | 2023-12-12 |
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