| Primary Device ID | 10884450178888 |
| NIH Device Record Key | fb0f435a-0c53-408a-8235-5d8b8d4bc765 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CPS H. Lee SafeSheath® Sealing Adapter |
| Version Model Number | 00884450178881 |
| Catalog Number | FCL-188-00 |
| Company DUNS | 065673912 |
| Company Name | Merit Medical |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450178881 [Primary] |
| GS1 | 10884450178888 [Package] Contains: 00884450178881 Package: [5 Units] In Commercial Distribution |
| DTL | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2017-03-30 |
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