| Primary Device ID | 00849405000419 |
| NIH Device Record Key | 425bf30e-71a1-4d02-86be-9ebe1df288a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XLR8 Canister |
| Version Model Number | A4-S00D8 |
| Company DUNS | 006616130 |
| Company Name | GENADYNE BIOTECHNOLOGIES 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849405000419 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-13 |
| Device Publish Date | 2024-08-05 |
| 00849405000426 | All canisters are made out of ABS material. It is used as a disposable item to collect patient†|
| 00849405000419 | All canisters are made out of ABS material. It is used as a disposable item to collect patient†|
| 00849405000402 | All canisters are made out of ABS material. It is used as a disposable item to collect patient†|
| 00849405000396 | All canisters are made out of ABS material. It is used as a disposable item to collect patient†|
| 00849405000051 | All canisters are made out of ABS material. It is used as a disposable item to collect patient†|