Identity
- Trade Name
- VitriThaw FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com). FDA UDI
- Model / Reference
- VT4001 FDA UDI
- Description
- VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) . For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life. For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967002139 FDA UDI
- 510(k) Number
- K070135 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: IVF medium
VitriThaw by Fertipro NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070135 also covers:
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
- Fertipro NV
Sources (1)
- FDA UDI f1a0abed-b170-429d-9d31-6fb39d840843 37 fields · synced May 29, 2026