M2.5PT Shiley Pediatric special trach

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: K945513

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

M2.5PT Shiley Pediatric special trach M6PDL Shiley Modified Long Pediatric Tracheostomy Tube M10FEN Shiley Modified Fenestrated Low Pressure Cuffed Tracheostomy Tube 5.5 PDL Shiley Long Pediatric Tracheostomy Tube M10CFS Shiley Modified Cuffless Tracheostomy Tube M5.5PED Shiley Modified Pediatric Tracheostomy Tube M4PT Shiley Pediatric special trach M4DCFN Shiley Modified Disposable Cannula Cuffless Fenestrated Tracheostomy Tube M8DCFS Shiley Modified Disposable Cannula Cuffless Tracheostomy Tube M6LPC Shiley Modified Low Pressure Cuffed Tracheostomy Tube M3PED Shiley Modified Pediatric Tracheostomy Tube M10SCT Shiley Modified Single Cannula Tracheostomy Tube M6.5SCT Shiley Modified Single Cannula Tracheostomy Tube M4LPC Shiley Modified Low Pressure Cuffed Tracheostomy Tube M7SCT Shiley Modified Single Cannula Tracheostomy Tube M0PT Shiley Pediatric special trach M8CFS Shiley Modified Cuffless Tracheostomy Tube M6PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube M8DFEN Shiley Modified Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube 5 PED Shiley Pediatric Tracheostomy Tube M000NT Shiley Neonatal specialized trach 4.5 NEO Shiley Neonatal Tracheostomy Tube 4 PED Shiley Pediatric Tracheostomy Tube M6SCT Shiley Modified Single Cannula Tracheostomy Tube M4SCT Shiley Modified Single Cannula Tracheostomy Tube M10DCT Shiley Modified Disposable Cannula Low Pressure Cuffed Tracheostomy Tube M4.5PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube M5.5PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube 3 NEO Shiley Neonatal Tracheostomy Tube M6.5PDL Shiley Modified Long Pediatric Tracheostomy Tube M5PED Shiley Modified Pediatric Tracheostomy Tube M7.5SCT Shiley Modified Single Cannula Tracheostomy Tube 3.5 NEO Shiley Neonatal Tracheostomy Tube M8DCFN Shiley Modified Disposable Cannula Cuffless Fenestrated Tracheostomy Tube 6 PDL Shiley Long Pediatric Tracheostomy Tube M10CFN Shiley Modified Cuffless Fenestrated Tracheostomy Tube 4.5 PED Shiley Pediatric Tracheostomy Tube M6FEN Shiley Modified Fenestrated Low Pressure Cuffed Tracheostomy Tube M10DCFN Shiley Modified Disposable Cannula Cuffless Fenestrated Tracheostomy Tube M10LGT Shiley Modified Laryngectomy Tube M10LPC Shiley Modified Low Pressure Cuffed Tracheostomy Tube M6DCFN Shiley Modified Disposable Cannula Cuffless Fenestrated Tracheostomy Tube M6DFEN Shiley Modified Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube M4PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube 3.5 PED Shiley Pediatric Tracheostomy Tube M5.5PDL Shiley Modified Long Pediatric Tracheostomy Tube M5PDC Shiley Modified Cuffed Pediatric Tracheostomy Tube M6DCT Shiley Modified Disposable Cannula Low Pressure Cuffed Tracheostomy Tube 5.5 PED Shiley Pediatric Tracheostomy Tube M8SCT Shiley Modified Single Cannula Tracheostomy Tube M4.5NEO Shiley Modified Neonatal Tracheostomy Tube 4 NEO Shiley Neonatal Tracheostomy Tube 6.5 PDL Shiley Long Pediatric Tracheostomy Tube M5PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube M6DCFS Shiley Modified Disposable Cannula Cuffless Tracheostomy Tube M4CFS Shiley Modified Cuffless Tracheostomy Tube M6CFN Shiley Modified Cuffless Fenestrated Tracheostomy Tube M4.5PED Shiley Modified Pediatric Tracheostomy Tube M00NT Shiley Neonatal specialized trach M5SCT Shiley Modified Single Cannula Tracheostomy Tube 5 PDL Shiley Long Pediatric Tracheostomy Tube 3 PED Shiley Pediatric Tracheostomy Tube M4FEN Shiley Modified Fenestrated Low Pressure Cuffed Tracheostomy Tube M3PT Shiley Pediatric special trach M10DCFS Shiley Modified Disposable Cannula Cuffless Tracheostomy Tube M3.5PT Shiley Pediatric special trach M3.5PED Shiley Modified Pediatric Tracheostomy Tube M000PT Shiley Pediatric special trach M8LGT Shiley Modified Laryngectomy Tube M4CFN Shiley Modified Cuffless Fenestrated Tracheostomy Tube M5PDL Shiley Modified Long Pediatric Tracheostomy Tube M6.5PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube M8DCT Shiley Modified Disposable Cannula Low Pressure Cuffed Tracheostomy Tube M10DFEN Shiley Modified Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube M4DCFS Shiley Modified Disposable Cannula Cuffless Tracheostomy Tube M6CFS Shiley Modified Cuffless Tracheostomy Tube M8FEN Shiley Modified Fenestrated Low Pressure Cuffed Tracheostomy Tube M00PT Shiley Pediatric special trach M3NEO Shiley Modified Neonatal Tracheostomy Tube M0NT Shiley Neonatal specialized trach M4DFEN Shiley Modified Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube M5.5PLC Shiley Modified Cuffed Long Pediatric Tracheostomy Tube M6LGT Shiley Modified Laryngectomy Tube M8LPC Shiley Modified Low Pressure Cuffed Tracheostomy Tube M2PT Shiley Pediatric special trach M1PT Shiley Pediatric special trach M4PED Shiley Modified Pediatric Tracheostomy Tube M9SCT Shiley Modified Single Cannula Tracheostomy Tube M1NT Shiley Neonatal specialized trach M3.5NEO Shiley Modified Neonatal Tracheostomy Tube M4NEO Shiley Modified Neonatal Tracheostomy Tube M8CFN Shiley ModifiedCuffless Fenestrated Tracheostomy Tube M5.5SCT Shiley Modified Single Cannula Tracheostomy Tube M4DCT Shiley Modified Disposable Cannula Low Pressure Cuffed Tracheostomy Tube

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)