| Primary Device ID | 00020221664218 |
| NIH Device Record Key | 584df49e-f1eb-4715-b3eb-702f3aea4721 |
| Commercial Distribution Discontinuation | 2025-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EXEL HYPO NDL 16GX1" BULK, NON-STERILE |
| Version Model Number | 26421BN |
| Catalog Number | 26421BN |
| 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 | 00020221664218 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
[00020221664218]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2025-10-07 |
| Device Publish Date | 2023-03-24 |
| 10020221664215 | EXEL HYPO NDL 16GX1" BULK, NON-STERILE |
| 00020221664218 | EXEL HYPO NDL 16GX1" BULK, NON-STERILE (2x10000 BAG) 20k/crtn |