| Primary Device ID | 00850066710272 |
| NIH Device Record Key | 0ace3cec-9c2a-46e4-9a9b-7f823ad22a3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simple HealthKit |
| Version Model Number | 1 |
| Company DUNS | 117058089 |
| Company Name | SIMPLE HEALTHKIT, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00850066710272 [Primary] |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-29 |
| Device Publish Date | 2026-01-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SIMPLE HEALTHKIT 97646743 not registered Live/Pending |
Simple HealthKit, Inc. 2022-10-25 |