| Primary Device ID | 00850013035205 |
| NIH Device Record Key | 5d3dab67-35be-41dd-9481-df38d9827e43 |
| Commercial Distribution Discontinuation | 2045-07-03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bicycle Health |
| Version Model Number | ID-BH9-ADULT-1-AZ25 |
| Catalog Number | ID-BH9-ADULT-1-AZ25 |
| Company DUNS | 064177324 |
| Company Name | MEDICAL DISTRIBUTION GROUP INC |
| Device Count | 25 |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850013035205 [Unit of Use] |
| GS1 | 10850013035202 [Primary] |
| DJG | Enzyme Immunoassay, Opiates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-01 |
| Device Publish Date | 2023-07-24 |
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