| Primary Device ID | 16974500612142 |
| NIH Device Record Key | 3a887141-3028-4b11-a46e-8d50fa95a768 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Closed Suction Catheter |
| Version Model Number | GC8061B12 |
| Company DUNS | 560122957 |
| Company Name | GCMEDICA ENTERPRISE LTD.(WUXI) |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974500612145 [Primary] |
| GS1 | 16974500612142 [Package] Contains: 06974500612145 Package: [10 Units] In Commercial Distribution |
| GS1 | 26974500612149 [Package] Package: [6 Units] In Commercial Distribution |
| BSY | Catheters, Suction, Tracheobronchial |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-14 |
| 16974500612166 | 72H, FR16, Double swivel connector with 30.5cm tube, with one-way irrigation port |
| 16974500612159 | 72H, FR14, Double swivel connector with 30.5cm tube, with one-way irrigation port |
| 16974500612142 | 72H, FR12, Double swivel connector with 30.5cm tube, with one-way irrigation port |
| 16974500612135 | 72H, FR10, Double swivel connector with 30.5cm tube, with one-way irrigation port |
| 16974500612128 | 72H, FR16, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port |
| 16974500612111 | 72H, FR14, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port |
| 16974500612104 | 72H, FR12, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port |
| 16974500612098 | 72H, FR10, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port |