| Primary Device ID | 00860004541752 |
| NIH Device Record Key | 33de8e38-0060-45c7-a2cc-98207d3f1aed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANNE Limb |
| Version Model Number | 810-00013 |
| Company DUNS | 093772547 |
| Company Name | Sibel Health Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00860004541752 [Primary] |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-10 |
| Device Publish Date | 2025-04-02 |
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