Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb 90165
GUDID 00857515006412
Continuous Single Culture® Complete with HSA
FUJIFILM IRVINE SCIENTIFIC, INC.
IVF medium| Primary Device ID | 00857515006412 |
| NIH Device Record Key | 8c6ad6e8-5990-4819-a43d-74f56227035d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb |
| Version Model Number | 90165-60mL |
| Catalog Number | 90165 |
| Company DUNS | 057475246 |
| Company Name | FUJIFILM IRVINE SCIENTIFIC, INC. |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
Operating and Storage Conditions
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857515006412 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121572
FDA Product Code
| MQL | Media, Reproductive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-23 |
| Device Publish Date | 2021-04-15 |
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Trademark Results [Continuous Single Culture]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONTINUOUS SINGLE CULTURE 85591724 4597623 Live/Registered |
FUJIFILM IRVINE SCIENTIFIC, INC. 2012-04-06 |
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