ISolate® Stock Solution 99275
GUDID 00857515006016
ISolate® Stock Solution
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 IVF medium 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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