| Primary Device ID | 00849405002659 |
| NIH Device Record Key | aac108f6-591c-41e7-b311-5d8f65edaa0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XLR8/XLR8+ Port - Unsterile |
| Version Model Number | XP-1013-UNS |
| Catalog Number | XP-1013-UNS |
| 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 | 00849405002659 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
[00849405002659]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-11 |
| Device Publish Date | 2025-12-03 |
| 00849405002598 - Hybrid Dressing | 2025-12-11 The Genadyne Hybrid Dressing kits which has a silicone adhesive dressing with green PU foam encapsulated in the middle, XLR8 Por |
| 00849405002659 - XLR8/XLR8+ Port - Unsterile | 2025-12-11Unsterile Medical grade suction port that has a PU film with acrylic adhesive attached to it. |
| 00849405002659 - XLR8/XLR8+ Port - Unsterile | 2025-12-11 Unsterile Medical grade suction port that has a PU film with acrylic adhesive attached to it. |
| 00849405002666 - XLR8 Transparent Film Dressing | 2025-12-11 Unsterile Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm. |
| 10849405002595 - Hybrid Dressing | 2025-12-11 Hybrid Dressing 10x20 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drape |
| 00849405000501 - AG Spiro Foam Kit | 2025-01-29 XLR8 PU Foam with AG Kit, Spiro |
| 00849405022114 - AG Foam Kit Small | 2025-01-29 XLR8 PU Foam with AG Kit, Small |
| 00849405022121 - AG Foam Kit Medium | 2025-01-29 XLR8 PU Foam with AG Kit, Medium |
| 00849405022138 - AG Foam Kit Large | 2025-01-29 XLR8 PU Foam with AG Kit, Large |