Hemolung® Cartridge Spare Parts Kit
GUDID 00850046004476
Hemolung® Cartridge Spare Parts Kit
Alung Technologies, Inc.
Mobile extracorporeal gas exchange system| Primary Device ID | 00850046004476 |
| NIH Device Record Key | 38e75543-8a9e-421e-b220-ce7936b7d7fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemolung® Cartridge Spare Parts Kit |
| Version Model Number | 41200 |
| Company DUNS | 129408592 |
| Company Name | Alung Technologies, 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850046004476 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN210006
FDA Product Code
| QOH | Extracorporeal System For Carbon Dioxide Removal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-01 |
| Device Publish Date | 2023-02-21 |
Devices Manufactured by Alung Technologies, Inc.
| 00850046004056 - Hemolung® CR4 Controller | 2023-03-01 Hemolung® CR4 Controller |
| 00850046004223 - Hemolung® Cartridge Kit | 2023-03-01 Hemolung® Cartridge Kit |
| 00850046004230 - Hemolung® Accessories Kit | 2023-03-01 Hemolung® Accessories Kit |
| 00850046004247 - Hemolung® Rinse Back Kit | 2023-03-01 Hemolung® Rinse Back Kit |
| 00850046004254 - Hemolung® Cartridge with Blood Tubing | 2023-03-01 Hemolung® Cartridge with Blood Tubing |
| 00850046004278 - Hemolung® 15.5 Fr Femoral Catheter Kit | 2023-03-01 Hemolung® 15.5 Fr Femoral Catheter Kit |
| 00850046004308 - Hemolung® 15.5 Fr Jugular Catheter Kit | 2023-03-01 Hemolung® 15.5 Fr Jugular Catheter Kit |
| 00850046004322 - Hemolung® Catheter Spare Parts Kit | 2023-03-01 Hemolung® Catheter Spare Parts Kit |
Trademark Results [Hemolung]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOLUNG 97051104 not registered Live/Pending |
ALung Technologies, Inc. 2021-09-29 |
 HEMOLUNG 77694732 3911641 Live/Registered |
ALung Technologies, Inc. 2009-03-19 |
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