| Primary Device ID | 07340153711815 |
| NIH Device Record Key | 459d5e3c-7fbe-4fde-9445-46bdcbf8cf09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultra Clean Systems |
| Version Model Number | Getinge 1150 |
| Company DUNS | 354023236 |
| Company Name | Getinge Disinfection AB |
| 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 | false |
| Lot Batch | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340153711815 [Primary] |
| FLG | Cleaner, Ultrasonic, Medical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 07340153716087 | WIRE MESH BASKET |
| 07340153716070 | XI ADAPTERS R2 - 10PK |
| 07340153716063 | XI ADAPTERS R2 - 6PK |
| 07340153716056 | D5 ADAPTERS 10PK |
| 07340153716049 | SP ADAPTER & HOSE ASS. KIT |
| 07340153716032 | D5 ADAPTERS 6PK |
| 07340153716025 | UDI LABEL D5 ADAPTER 1 |
| 07340153716018 | X/XI ADAPTERS 6PK |
| 07340153716001 | ADAPTERS,TRITON XI,10 PACK |
| 07340153715974 | TRITON_WIRE MESH_BARCODE TAG ASSEMBLY |
| 07340153715943 | BASKET W/ADPTR KIT, 1150/1522 10-0025 |
| 07340153715929 | RAC Xi TRAY,TRITON W/SP ADPTRS 10-0324 |
| 07340153715912 | RAC Xi TRAY,TRITON 10-0324 |
| 07340153715905 | RACS BASKET, Xi ADAPTERS 10-0324 |
| 07340153715899 | RACS BASKET, S/SI ADAPTERS 10-0158 |
| 07340153715882 | BASKET W/ADAPTER KIT, 36, 72 10-0158 |
| 07340153715851 | ROBOTIC ARM CLEANING BASKET 10-0312 |
| 07340153715844 | BASKET ASSEMBLY, TRITON 36, 72 10-0158 |
| 07340153715837 | BASKET ASSEMBLY, 1150, 1522 10-0155 |
| 07340153711846 | Getinge Triton 72 |
| 07340153711839 | Getinge Triton 36 |
| 07340153711822 | Getinge 1522 |
| 07340153711815 | Getinge 1150 |