The following data is part of a premarket notification filed by Carefusion 2200 Inc with the FDA for Genesis Low Temperature Reusable Rigid Container System.
| Device ID | K153554 |
| 510k Number | K153554 |
| Device Name: | Genesis Low Temperature Reusable Rigid Container System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CareFusion 2200 Inc 75 N. Fairway Drive Vernon Hills, IL 60061 |
| Contact | Jane Weber |
| Correspondent | Jane Weber CareFusion 2200 Inc 75 N. Fairway Drive Vernon Hills, IL 60061 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403418112 | K153554 | 000 |
| 10885403417016 | K153554 | 000 |
| 10885403417009 | K153554 | 000 |
| 10885403416996 | K153554 | 000 |
| 10885403416989 | K153554 | 000 |
| 10885403416972 | K153554 | 000 |
| 10885403416965 | K153554 | 000 |
| 10885403416958 | K153554 | 000 |
| 10885403497827 | K153554 | 000 |
| 10885403497810 | K153554 | 000 |
| 10885403497803 | K153554 | 000 |
| 10885403497797 | K153554 | 000 |
| 10885403497780 | K153554 | 000 |
| 10885403497773 | K153554 | 000 |
| 10885403497766 | K153554 | 000 |
| 10885403497759 | K153554 | 000 |
| 10885403497742 | K153554 | 000 |
| 10885403497735 | K153554 | 000 |
| 10885403417689 | K153554 | 000 |
| 10885403417696 | K153554 | 000 |
| 10885403418105 | K153554 | 000 |
| 10885403418099 | K153554 | 000 |
| 10885403418082 | K153554 | 000 |
| 10885403418075 | K153554 | 000 |
| 10885403418068 | K153554 | 000 |
| 10885403418051 | K153554 | 000 |
| 10885403418006 | K153554 | 000 |
| 10885403417993 | K153554 | 000 |
| 10885403417986 | K153554 | 000 |
| 10885403417979 | K153554 | 000 |
| 10885403417962 | K153554 | 000 |
| 10885403417955 | K153554 | 000 |
| 10885403417948 | K153554 | 000 |
| 10885403417931 | K153554 | 000 |
| 10885403417924 | K153554 | 000 |
| 10885403417719 | K153554 | 000 |
| 10885403417702 | K153554 | 000 |
| 10885403497728 | K153554 | 000 |