ISolate® Stock Solution 99275
GUDID 00857515006016
ISolate® Stock Solution
FUJIFILM IRVINE SCIENTIFIC, INC.
IVF medium| Primary Device ID | 00857515006016 |
| NIH Device Record Key | 40dd0210-da3b-4358-8022-d57784df8b13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ISolate® Stock Solution |
| Version Model Number | 99275-500ML |
| Catalog Number | 99275 |
| 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 | false |
| Single Use | true |
| 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 | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 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 |
| 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 | 00857515006016 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991341
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 | 4 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2016-09-10 |
On-Brand Devices [ISolate® Stock Solution]
| 00857515006269 | ISolate® Stock Solution Custom packaging configuration. Only distributed in Japan. |
| 00857515006016 | ISolate® Stock Solution |
Trademark Results [ISolate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOLATE 87905919 not registered Dead/Abandoned |
Bowtech, Inc. 2018-05-03 |
 ISOLATE 79253930 not registered Live/Pending |
Flare Audio Technologies Limited 2018-12-18 |
 ISOLATE 78901016 3253457 Live/Registered |
ISOLATE DENTAL INC. 2006-06-05 |
 ISOLATE 78744118 3221825 Dead/Cancelled |
ASTRONICS TEST SYSTEMS INC. 2005-10-31 |
 ISOLATE 76313525 not registered Dead/Abandoned |
RACAL INSTRUMENTS, INC. 2001-09-18 |
 ISOLATE 75353375 not registered Dead/Abandoned |
Lake Region Manufacturing, Inc. 1997-09-08 |
 ISOLATE 75140878 2090259 Live/Registered |
FUJIFILM IRVINE SCIENTIFIC, INC. 1996-07-29 |
 ISOLATE 74338516 1785188 Dead/Cancelled |
L & S RESEARCH CORPORATION 1992-12-09 |
 ISOLATE 74323284 not registered Dead/Abandoned |
Lake Region Manufacturing Company, Inc. 1992-10-19 |
 ISOLATE 71536683 0545040 Dead/Expired |
FOOTE & JENKS, INC. 1947-10-03 |
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