| Primary Device ID | 00850540007157 |
| NIH Device Record Key | 14b7a0b2-02dd-4045-a8f4-67589821a15b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SigmaPace 1000 |
| Version Model Number | SIGMAP1K-USA120V |
| Catalog Number | 2247700 |
| Company DUNS | 002687614 |
| Company Name | FLUKE ELECTRONICS CORPORATION |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850540007157 [Primary] |
| DTC | Analyzer, Pacemaker Generator Function |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-24 |
| 00850540007218 - ESA 614 | 2019-04-12 Electrical Safety Analyzer |
| 00850540007065 - ProSim 8 | 2018-07-06 Vital Signs Patient Simulator |
| 00850540007072 - ProSim 4 | 2018-07-06 Vital Signs Patient Simulator |
| 00850540007089 - ProSim 2 | 2018-07-06 Vital Signs Patient Simulator |
| 00850540007096 - ProSim 3 | 2018-07-06 Vital Signs Patient Simulator |
| 00850540007102 - ProSim SPOT Light | 2018-07-06 SpO2 Pulse Oximeter Analyzer |
| 00850540007119 - Impulse 6000D | 2018-07-06 Defibrillator Analyzer |
| 00850540007133 - Impulse 4000 | 2018-07-06 Defibrillator/Pacer Analyzer |