| Primary Device ID | 10816317023734 |
| NIH Device Record Key | c4b968d2-6a37-4997-8c4c-5d01add7e7d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ECG Leads |
| Version Model Number | RM-33111 |
| 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 | true |
| 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 | 00816317023737 [Primary] |
| GS1 | 10816317023734 [Package] Contains: 00816317023737 Package: case [10 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 | 2019-09-12 |
| Device Publish Date | 2019-09-04 |
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| 00816317024314 - Kendall ECG Leads | 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 72in |
| 10816317024328 - Kendall ECG Leads | 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 72in |
| 10816317024335 - Kendall ECG Leads | 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 36in |
| 10816317024342 - Kendall ECG Leads | 2025-05-09 Covidien Kendall - DUAL CONNECT LEADSET 3 LEAD 10 pin 36in |
| 10816317024359 - Kendall ECG Leads | 2025-05-09 Covidien Kendall - DISPOSIBLE PH V TELEMETRY 5 LEAD 10 Pin 39in |