Early Cleavage Medium 90138
GUDID 00893727002248
Early Cleavage Medium (ECM) with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium 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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| 00893727002941 - Modified Ham's F-10 with Albumin | 2024-02-12 Modified Ham's F-10 w/Albumin |
| 00893727002835 - Modified Ham's F-10 Basal Medium - HEPES | 2023-12-08 Modified Ham's F-10 Basal Medium - HEPES |
| 00857515006337 - Heavy Oil for Embryo Culture | 2022-07-21 Heavy Oil for Embryo Culture |
| 00857515006344 - Heavy Oil for Embryo Culture | 2022-07-21 Heavy Oil for Embryo Culture |
| 00893727002248 - Early Cleavage Medium | 2022-03-31Early Cleavage Medium (ECM) with Gentamicin |
| 00893727002248 - Early Cleavage Medium | 2022-03-31 Early Cleavage Medium (ECM) with Gentamicin |
| 00893727002989 - Polyvinylpyrrolidone (PVP) - Lyophilized | 2022-01-06 PVP (polyvinylpyrrolidone) |
| 00893727002286 - Complete Early Cleavage Medium with DSS | 2021-10-20 Complete Early Cleavage (ECM) With DSS |
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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