| Primary Device ID | 10816317024052 |
| NIH Device Record Key | 47cab67b-ecdb-4648-a6cc-8ba5e6e04dea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advantage Medical Cable ECG Leads |
| Version Model Number | RM-LWM-309DS120/5AT |
| Company DUNS | 100439103 |
| Company Name | RENU MEDICAL, INC |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 00816317024055 [Primary] |
| GS1 | 10816317024052 [Package] Contains: 00816317024055 Package: [25 Units] In Commercial Distribution |
| GS1 | 20816317024059 [Package] Contains: 00816317024055 Package: Case [20 Units] In Commercial Distribution |
| IKD | Cable, Electrode |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-13 |
| Device Publish Date | 2023-04-05 |
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