| Primary Device ID | 00810195240446 |
| NIH Device Record Key | 1619ceea-9f51-4de7-922d-a4ef5641901e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thawing Solution Add-On Pack |
| Version Model Number | 90134-TPACK |
| Catalog Number | 90134-TPACK |
| Company DUNS | 121584789 |
| Company Name | IRVINE SCIENTIFIC, LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810195240446 [Primary] |
| MQL | Media, Reproductive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-10 |
| Device Publish Date | 2025-06-02 |
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| 00810195240033 - cryo-GO Vitrification Device - Green (Pack of 10) | 2025-06-10 cryo-GO Vitrification Device - Green (Pack of 10). A device composed of a body and a cap for use in ART procedures which includ |
| 00810195240040 - cryo-GO Vitrification Device - Purple (Pack of 10) | 2025-06-10 cryo-GO Vitrification Device - Purple (Pack of 10). A device composed of a body and a cap for use in ART procedures which inclu |
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| 00810195240064 - cryo-GO Vitrification Device - Yellow (Pack of 50) | 2025-06-10 cryo-GO Vitrification Device - Yellow (Pack of 50). A device composed of a body and a cap for use in ART procedures which inclu |
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