| Primary Device ID | 00893727002415 |
| NIH Device Record Key | 5c267aec-a5b0-437b-907b-c5cbd35ab44a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colcemid Solution |
| Version Model Number | 9311-10ml |
| Catalog Number | 9311 |
| Company DUNS | 057475246 |
| Company Name | FUJIFILM IRVINE SCIENTIFIC, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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 | true |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 120 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857515006306 [Primary] |
| GS1 | 00893727002415 [Primary] |
| KIQ | Kit, Culture, Chromosome |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-03 |
| Device Publish Date | 2021-04-23 |
| 00893727002200 - Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin | 2025-04-14 Freezing Medium With Gentamicin |
| 00893727002361 - ISolate® | 2025-04-14 ISolate |
| 00893727002903 - Human Serum Albumin Solution | 2025-04-14 Human Albumin |
| 00893727002620 - Multipurpose Handling Medium® (MHM®) | 2025-03-31 Multipurpose Handling Medium® with Gentamicin |
| 00893727002637 - Multipurpose Handling Medium® (MHM®) | 2025-03-31 Multipurpose Handling Medium® with Gentamicin |
| 00893727002644 - Continuous Single Culture® | 2025-03-31 Continuous Single Culture® with Gentamicin |
| 00893727002651 - Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb | 2025-03-31 Continuous Single Culture® Complete with HSA |
| 00893727002712 - Multipurpose Handling Medium®-Complete (MHM®-C) | 2025-03-31 Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin |