| Primary Device ID | 00898302001005 |
| NIH Device Record Key | d369c4f2-9413-4fbb-981e-779479cb3458 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simple Diagnostics |
| Version Model Number | LAND |
| Catalog Number | 98302-0001-00 |
| Company DUNS | 004135503 |
| Company Name | SIMPLE DIAGNOSTICS 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 | 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00898302001005 [Primary] |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2020-09-01 |
| 00898302140698 - Clever Choice | 2023-02-22 Replacement Cuff for Automatic Blood Pressure Monitors. Arm testing site. |
| 10850002860600 - Pharmacist Choice | 2022-10-27 Simple Diagnostics Blood Lancets |
| 20898302140203 - Comfort EZ Safety Lancet | 2022-10-27 Safety Lancet 28G 1.5mm Depth |
| 10898302140121 - Clever Choice | 2022-06-15 Automatic Blood Pressure Monitor with Wide Range Cuff. Arm testing site. Also measures heart rate. Displays Blood Pressure readi |
| 00898302001449 - Clever Choice | 2022-06-10 Clever Choice Whisper Aire Nebulizer with mask and tubing |
| 10898302001453 - Clever Choice | 2022-06-10 Clever Choice Whisper Aire Pediatric Child Nebulizer with mask and tubing |
| 10898302140190 - Clever Choice | 2022-01-12 Clever Choice Disposable Face Masks - Medical |
| 10898302140183 - Clever Choice | 2021-11-10 Clever Choice Deluxe Pulse Oximeter |