| Primary Device ID | 10816317024359 |
| NIH Device Record Key | 3a1daef6-63b4-41e1-a625-e53554952bb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kendall ECG Leads |
| Version Model Number | RM-33113 |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816317024352 [Primary] |
| GS1 | 10816317024359 [Package] Contains: 00816317024352 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 | 2025-05-09 |
| Device Publish Date | 2025-05-01 |
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| 10816317024359 | Covidien Kendall - DISPOSIBLE PH V TELEMETRY 5 LEAD 10 Pin 39in |
| 10816317024342 | Covidien Kendall - DUAL CONNECT LEADSET 3 LEAD 10 pin 36in |
| 10816317024335 | Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 36in |
| 10816317024328 | Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 72in |
| 00816317024314 | Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 72in |
| 10816317024304 | Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 36in |
| 00816317024291 | Cardinal Health Kendall Philips INTEL TELE LEAD SET WITH SHOWER SHIELD 5 Lead 5 Pin 50in |