| Primary Device ID | 10860000526590 |
| NIH Device Record Key | 9ccf1a29-5995-4c51-9369-8a13ab94c7fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pure Comfort Peak Flow Meter ADULT |
| Version Model Number | EP70101 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 1-800-915-0116 |
| info@homeaide.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000526593 [Primary] |
| GS1 | 10860000526590 [Package] Contains: 00860000526593 Package: Inner Carton [25 Units] In Commercial Distribution |
| GS1 | 20860000526597 [Package] Package: Outer Carton [4 Units] In Commercial Distribution |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-31 |
| Device Publish Date | 2020-03-23 |
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| 10850058864089 - Easy Comfort 3L Sharps Container {3.17 Quarts} | 2024-06-24 3L Sharps Container {3.17 Quarts} |
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