| Primary Device ID | 10850027494439 |
| NIH Device Record Key | 12391269-f51f-41f3-8cdd-e62275f09d72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | True Comfort Safety Pen Needles 5MM 31G |
| Version Model Number | 1 |
| Company DUNS | 783518983 |
| Company Name | HOME AIDE DIAGNOSTICS, INC. |
| 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 | 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 | 1-800-915-0116 |
| info@homeaide.us |
| Needle Gauge | 31 Gauge |
| Length | 5 Millimeter |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027494432 [Primary] |
| GS1 | 10850027494439 [Package] Contains: 00850027494432 Package: Outer Carton [20 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-09-30 |
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