| Primary Device ID | 10855364004112 |
| NIH Device Record Key | 20e579c0-4590-4acd-a5cd-58d31d9cfc3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rhino-Pak 45mm |
| Version Model Number | RP-45 |
| Company DUNS | 176664068 |
| Company Name | MAR-MED INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Balloon Length | 45 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855364004115 [Primary] |
| GS1 | 10855364004112 [Package] Contains: 00855364004115 Package: Box [10 Units] In Commercial Distribution |
| EMX | Balloon, Epistaxis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-14 |
| Device Publish Date | 2025-02-06 |
| 00855364004146 - ZeroWet | 2025-05-23 Zerowet SuperShield (Individual Unit) |
| 00855364004153 - ZeroWet | 2025-05-23 ZeroWet Klenzalac Kit |
| 10855364004112 - Rhino-Pak 45mm | 2025-02-14Lubricious Epistaxis Balloon - 45mm |
| 10855364004112 - Rhino-Pak 45mm | 2025-02-14 Lubricious Epistaxis Balloon - 45mm |
| 00855364004122 - Rhino-Pak 55mm | 2025-02-14 Lubricious Epistaxis Balloon - 55mm |
| 10855364004136 - Rhino-Pak 75mm | 2025-02-14 Lubricious Epistaxis Balloon - 75mm |
| 10855364004037 - Tourni-Cot - Small | 2020-10-01 Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. |
| 00855364004047 - Tourni-Cot - Medium | 2020-10-01 Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. |
| 00855364004054 - Tourni-Cot - Large | 2020-10-01 Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. |