| Primary Device ID | 05705244027060 |
| NIH Device Record Key | 6b4c2357-bd05-42e1-9c58-77fa9ea4645a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iLet Flex |
| Version Model Number | FG000063-03 |
| 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 |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Angle | 90 degree |
| Length | 60 Centimeter |
| Depth | 6 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location at room temperature. Do not store in direct sunlight, or in 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 in 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 in 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 in 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 in 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 in 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 in high humidity. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05705244027060 [Package] Contains: 05705244027084 Package: [2 Units] In Commercial Distribution |
| GS1 | 05705244027077 [Package] Package: [36 Units] In Commercial Distribution |
| GS1 | 05705244027084 [Primary] |
| FPA | Set, administration, intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-14 |
| 05705244027183 | ilet Flex, 9mm, 80cm 2 pack |
| 05705244027152 | ilet Flex, 9mm, 60cm 2 pack |
| 05705244027138 | ilet Flex, 9mm, 46cm 2 pack |
| 05705244027107 | ilet Flex, 6mm, 80cm 2pack |
| 05705244027060 | ilet Flex, 6mm, 60cm 2 pack |
| 05705244027046 | ilet Flex, 6mm, 46cm 2 pack |
| 05705244027015 | ilet Flex, 9mm, 80cm 10 pack |
| 05705244026988 | ilet Flex, 9mm, 60cm 10 pack |
| 05705244026957 | ilet Flex, 9mm, 46cm 10 pack |
| 05705244026926 | ilet Flex, 6mm, 80cm 10 pack |
| 05705244026889 | ilet Flex, 6mm, 60cm 10 pack |
| 05705244026865 | ilet Flex, 6mm, 46cm 10 pack |