| Primary Device ID | 00849405001454 |
| NIH Device Record Key | 3060e5bf-2552-46eb-a139-03d27874ffed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XLR8/XLR8+ Port |
| Version Model Number | XP-1013 |
| Catalog Number | XP-1013 |
| 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 | 00849405001454 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
[00849405001454]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-27 |
| Device Publish Date | 2023-12-19 |
| 00849405000013 - XLR8 Transparent Film Dressing | 2023-12-27 Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm. |
| 00849405001454 - XLR8/XLR8+ Port | 2023-12-27Medical grade suction port that has a PU film with acrylic adhesive attached to it. |
| 00849405001454 - XLR8/XLR8+ Port | 2023-12-27 Medical grade suction port that has a PU film with acrylic adhesive attached to it. |
| 00849405000389 - UNO Plus 200 CC Collection Canister | 2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: |
| 00849405000488 - UNO Plus 300 CC Collection Canister | 2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: |
| 00849405000495 - UNO Plus Negative Pressure Wound Therapy Device | 2023-06-21 The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for mo |
| 00849405000525 - UNO 10x10 Dressing kit | 2023-06-19 The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is att |
| 00849405000532 - UNO 15 Therapy Kit 10x10 | 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The |
| 00849405000549 - UNO 7 Therapy Kit 10x10 | 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The |