Early Cleavage Medium 90138
GUDID 00893727002248
Early Cleavage Medium (ECM) with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
IVF medium| Primary Device ID | 00893727002248 |
| NIH Device Record Key | 2f562a57-4d2f-48aa-9beb-7e77d1997335 |
| Commercial Distribution Discontinuation | 2022-04-29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Early Cleavage Medium |
| Version Model Number | 90138-60mL |
| Catalog Number | 90138 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893727002248 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033462
FDA Product Code
| MQL | Media, Reproductive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-03-31 |
| Device Publish Date | 2016-09-10 |
Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.
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| 00893727002071 - Sperm Washing Medium | 2025-06-16 Sperm Washing Medium |
| 00893727002088 - Sperm Washing Medium | 2025-06-16 Sperm Washing Medium |
| 00893727002101 - Human Serum Albumin Solution | 2025-06-16 Human Serum Albumin Solution |
| 00893727002125 - Hyaluronidase Solution | 2025-06-16 Hyaluronidase |
| 00893727002163 - 7% PVP Solution with HSA | 2025-06-16 Polyvinylpyrrolidone (PVP) Solution with HSA - 7% |
| 00893727002170 - 10% PVP Solution with HSA | 2025-06-16 Polyvinylpyrrolidone (PVP) Solution with HSA - 10% |
Trademark Results [Early Cleavage Medium]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EARLY CLEAVAGE MEDIUM 78309190 2911866 Live/Registered |
FUJIFILM IRVINE SCIENTIFIC, INC. 2003-10-03 |
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