| Primary Device ID | 00020221664249 |
| NIH Device Record Key | 63584694-8ffa-4594-8c65-f6470eee3309 |
| Commercial Distribution Discontinuation | 2025-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EXEL HYPO NDL 19GX1" BULK, N-S |
| Version Model Number | 26424BN |
| Catalog Number | 26424BN |
| Company DUNS | 180572216 |
| Company Name | Exel International |
| 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00020221664249 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
[00020221664249]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-10-07 |
| Device Publish Date | 2023-03-24 |
| 10020221664246 | EXEL HYPO NDL 19GX1" BULK, N-S 20,000/CRTN |
| 00020221664249 | EXEL HYPO NDL 19GX1" BULK, N-S 20,000/CRTN |