6FENJ-S Shiley LOW PRESSURE CUFF WITH EVAC

Registration Details

Registration Name: Sterigenics U.S., LLC
Registration Number: 1721686
FEI Number: 1721686
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 2400 Airport Rd
City: Santa Teresa
State: NM
ZIP: 88008
Country: US

Regulatory Submissions

510(k) Number: K962173

Owner / Operator

Firm Name: Sotera Health LLC
Operator Number: 10029425
Address: 2015 Spring Road, Suite 650
City: Oak Brook
State: IL
Postal Code: 60523
Country: US
Correspondent: Karen Whaley-Krumins

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Tube Tracheostomy And Tube Cuff	JOH	Class 2	Anesthesiology	No	2013-06-06

Proprietary Names

6FENJ-S Shiley LOW PRESSURE CUFF WITH EVAC 7SCT Shiley Single Cannula Tracheostomy Tube 4DCFS Shiley Disposable Cannula Cuffless Tracheostomy Tube 6CFNJ Shiley JPNFE TRACH W/O CUF, 6 BX 8FENJ Shiley FEN LPC, 8 BX 6CFS Shiley Cuffless Tracheostomy Tube 6DICFEN Shiley Accessories/ Fenestrated Disposable Inner Cannula 9SCT Shiley Single Cannula Tracheostomy Tube 10CFN Shiley Cuffless Fenestrated Tracheostomy Tube 10DFEN Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube 6SCT Shiley Single Cannula Tracheostomy Tube 4DICFEN Shiley Accessories/ Fenestrated Disposable Inner Cannula 10DCT Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube 10FENJ Shiley FEN LPC, 10 BX 10LGT Shiley Laryngectomy Tube 4CFN Shiley Cuffless Fenestrated Tracheostomy Tube 8FENJ-S Shiley LOW PRESSURE CUFF WITH EVAC 6DCT Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube 6LPC Shiley Low Pressure Cuffed Tracheostomy Tube 8LGT Shiley Laryngectomy Tube 8CFS Shiley Cuffless Tracheostomy Tube 8CFNJ Shiley JPNFE TRACH W/O CUF, 8 BX 8DFEN Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube 6FENJ Shiley FEN LPC, 6 BX 6FEN Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube 10LPC-S Shiley Evac Low Pressure Cuffed Tracheostomy Tube 10LPC Shiley Low Pressure Cuffed Tracheostomy Tube 10CFNJ Shiley JPNFE TRACH W/O CUF, 10 BX 10DCFS Shiley Disposable Cannula Cuffless Tracheostomy Tube 8CFN Shiley Cuffless Fenestrated Tracheostomy Tube 4CFS Shiley Cuffless Tracheostomy Tube 10DICFEN Shiley Accessories/ Fenestrated Disposable Inner Cannula 6DCFN Shiley Disposable Cannula Cuffless Fenestrated Tracheostomy Tube 4DCFN Shiley Disposable Cannula Cuffless Fenestrated Tracheostomy Tube 10SCT Shiley Single Cannula Tracheostomy Tube 10FEN Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube 4LPC-S Shiley Evac Low Pressure Cuffed Tracheostomy Tube 8SCT Shiley Single Cannula Tracheostomy Tube 10FENJ-S Shiley LOW PRESSURE CUFF WITH EVAC 8FEN Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube 8LPC-S Shiley Evac Low Pressure Cuffed Tracheostomy Tube 4LPC Shiley Low Pressure Cuffed Tracheostomy Tube 10CFS Shiley Cuffless Tracheostomy Tube 4CFNJ Shiley JPNFE TRACH W/O CUF, 4 BX 6LPC-S Shiley Evac Low Pressure Cuffed Tracheostomy Tube 5SCT Shiley Single Cannula Tracheostomy Tube 4FENJ-S Shiley LOW PRESSURE CUFF WITH EVAC 6LGT Shiley Laryngectomy Tube 4DCT Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube 8DCT Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube 6DCFS Shiley Disposable Cannula Cuffless Tracheostomy Tube 8DICFEN Shiley Accessories/ Fenestrated Disposable Inner Cannula 4DFEN Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube 8LPC Shiley Low Pressure Cuffed Tracheostomy Tube 10DCFN Shiley Disposable Cannula Cuffless Fenestrated Tracheostomy Tube 4FENJ Shiley FEN LPC, 4 BX 8DCFN Shiley Disposable Cannula Cuffless Fenestrated Tracheostomy Tube 6DFEN Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube 6CFN Shiley Cuffless Fenestrated Tracheostomy Tube 4FEN Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube 8DCFS Shiley Disposable Cannula Cuffless Tracheostomy Tube

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)