Lifogen 31-10-6515
GUDID 00260720012114
Kit, Soft-Case
ALLIED HEALTHCARE PRODUCTS, INC.
Respiratory oxygen therapy system| Primary Device ID | 00260720012114 |
| NIH Device Record Key | 52374fbe-ef35-4478-8f8a-590a6499aab3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lifogen |
| Version Model Number | 31-10-6515 |
| Catalog Number | 31-10-6515 |
| Company DUNS | 099674145 |
| Company Name | ALLIED HEALTHCARE PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00260720012114 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K802644
FDA Product Code
| CAN | Regulator, Pressure, Gas Cylinder |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-12 |
| Device Publish Date | 2016-09-07 |
On-Brand Devices [Lifogen]
| 00260720012114 | Kit, Soft-Case |
| 00260720011018 | Emergency Oxygen Unit |
| 00026072011010 | Emergency Oxygen Unit |
| 00026072012116 | Kit, Soft-Case |
Trademark Results [Lifogen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIFOGEN 97908649 not registered Live/Pending |
MOLAVI SALMAN 2023-04-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.