FDA Registration Active 🇺🇸 United States

Interlink Continu-Flo Solution Set w/ Kippmed Manifold & Elcam Polysulfone Stopcock

Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sterigenics US LLC
Registration Number
3002907620
FEI Number
3002907620
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1700 College Blvd.
City
West Memphis
State
AR
ZIP
72301
Country
US

Regulatory Submissions

510(k) Number
K932512

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
Stopcock, I.V. Set FMG

Proprietary Names

Interlink Continu-Flo Solution Set w/ Kippmed Manifold & Elcam Polysulfone Stopcock Interlink Continu-Flo 3 Port Manifold Elcam Polysulfone Stopcock 3 Port Manifold Continu-Flo Solution Set with Manifold Interlink Continu-Flo with Kippmed 3 Port Manifold Kippmed Manifold Extension Set w/ Elcam Polysulfone Stopcock Interlink Ext. with 3 Port Kippmed Manifold Interlink Ext. with 3 Port Manifold, Elcam Polysulfone Stopcock Continu-Flo Solution Set Smiths Medical Blood Recipient Set

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)