| Primary Device ID | 10849296007099 |
| NIH Device Record Key | 2066f011-8d79-4c28-8ed9-be6bd45e1801 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 1224-SC4470FFT |
| Company DUNS | 828213426 |
| Company Name | WELMED 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849296007092 [Primary] |
| GS1 | 10849296007099 [Package] Contains: 00849296007092 Package: [20 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
[10849296007099]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2017-06-14 |
| 00849296009898 - Welmed | 2026-02-23 Cysto-Bladder, Irrigation Set, 81”, Roller Clamp, 40 per case |
| 00849296009911 - Welmed | 2026-02-23 Y-type TUR, Bladder-Irrigation Set, 81”, 40 per case |
| 00849296013345 - Welmed | 2026-02-23 Syringe, 1cc, TB, Non-Sterile Bulk, 250 each/ bag, 20/bag, 5000 each/case |
| 00849296013352 - Welmed | 2026-02-23 Syringe, 2cc, Luer Lock, 3600 each/case |
| 00849296013369 - Welmed | 2026-02-23 Syringe, 3cc, Luer Lock, Non-Sterile Bulk, 3800 each/case |
| 00849296013376 - Welmed | 2026-02-23 Syringe, 3cc, Luer Slip, 3800 each/case |
| 00849296013383 - Welmed | 2026-02-23 Syringe, 5cc, Luer Lock, Non-Sterile Bulk, 900 each/bag, 2 bags/case, 1800 each/case |
| 00849296013390 - Welmed | 2026-02-23 Syringe, 5cc, Luer Slip, 900 each/bag, 2 bags/case, 1800 each/case |