| Primary Device ID | 10860003125561 |
| NIH Device Record Key | b2f0236f-d168-440f-9879-a6415fe2a0da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pure Comfort Twist Top Lancets 30G |
| Version Model Number | PureCSafety30 |
| Company DUNS | 783518983 |
| Company Name | HOME AIDE 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us | |
| Phone | 18009150116 |
| info@homeaide.us |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Needle Gauge | 30 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003125564 [Primary] |
| GS1 | 10860003125561 [Package] Contains: 00860003125564 Package: Outer Carton [100 Units] In Commercial Distribution |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2020-02-26 |
| 10860003125554 | • 30 Gauge • Twist top lancets • Single use • Provides virtually painless testing †|
| 10860003125561 | One handed use No lancing device required Automatic needle retraction Lock out after use prevent |