| Primary Device ID | 00190790000417 |
| NIH Device Record Key | f6588738-b2b3-4bac-bf89-846c952b77d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 93H ProFlexx® |
| Version Model Number | 0015762 |
| Company DUNS | 004239034 |
| Company Name | FERNO-WASHINGTON, INC. |
| 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 |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com | |
| Phone | 937-283-2950 |
| complaintcoordinator@ferno.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190790000417 [Primary] |
| FPO | Stretcher, Wheeled |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-22 |
| 00190790000424 | 93H ProFlexx®, Blue FOF ROSA |
| 00190790000417 | 93H ProFlexx®, Red FOF ROSA |
| 00190790000400 | 93H ProFlexx®, Blue FOF USA |
| 00190790000394 | 93H ProFlexx®, Red FOF USA |