| Primary Device ID | 00860004811343 |
| NIH Device Record Key | 8f693d59-36f8-47e2-8668-432d69d4e24c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NPseal |
| Version Model Number | GM01-001 |
| Company DUNS | 118095992 |
| Company Name | Guard Medical Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com | |
| Phone | 8884173644 |
| info@guard-medical.com |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Handling Environment Temperature | Between 0 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture during storage |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004811343 [Primary] |
| GS1 | 10860004811340 [Package] Package: [10 Units] In Commercial Distribution |
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-08-29 |
| Device Publish Date | 2021-06-07 |
| 00860004811367 | 15 Negative Pressure Wound Therapy Dressing |
| 00860004811350 | 10 Negative Pressure Wound Therapy Dressing |
| 00860004811343 | 5 Negative Pressure Wound Therapy Dressing |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NPSEAL 88000721 not registered Live/Pending |
Guard Medical SAS 2018-06-14 |