Identity
- Trade Name
- ISolate® Concentrate FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- ISolate Custom package configuration FDA UDI
- Model / Reference
- 99306-1L FDA UDI
- Description
- ISolate Custom package configuration FDA UDI
Identifiers
- Catalog Number
- 99306 FDA UDI
- Primary DI / UDI-DI
- 00857515006023 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Liter FDA UDI
Category: IVF medium
ISolate® Concentrate by Fujifilm Irvine Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
Sources (1)
- FDA UDI 5499e179-71f0-47f5-85d2-e3149b2e9004 37 fields · synced May 30, 2026