| Primary Device ID | 05705244026346 |
| NIH Device Record Key | b6ce3a34-aa31-47c3-8cce-24eca7300620 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inset II |
| Version Model Number | 1014322 |
| Company DUNS | 306032491 |
| Company Name | Unomedical A/S |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com | |
| Phone | +18004228811 |
| cic12@convatec.com |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Angle | 90 degree |
| Depth | 6 Millimeter |
| Length | 12 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight or high humidity. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05705244026346 [Package] Contains: 05705244026360 Package: [2 Units] In Commercial Distribution |
| GS1 | 05705244026353 [Package] Package: [60 Units] In Commercial Distribution |
| GS1 | 05705244026360 [Primary] |
| FPA | Set, administration, intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-11-06 |
| 05705244026346 | Single use infusion set for subcutaneous infusion. The infusion set must be used as described in |
| 05705244026322 | Single use infusion set for subcutaneous infusion. The infusion set must be used as described in |