Identity
- Trade Name
- Vitrification Kit FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- SAGE Vitriifcation Kit. ART-8025-A: 1x2 ml Equilibration Solution, ART-8025-B: 1x2 ml Vitriifcation Solution. FDA UDI
- Model / Reference
- ART-8025 FDA UDI
- Description
- SAGE Vitriifcation Kit. ART-8025-A: 1x2 ml Equilibration Solution, ART-8025-B: 1x2 ml Vitriifcation Solution. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937819511 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium kit 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
Yes
FDA UDI
Combination Product
Yes
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
Category: IVF medium kit
Vitrification Kit by Origio A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as IVF medium kit.
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- Ultra-Fast Vitri — KITAZATO CORPORATION · Class II
- G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- G-Vitri™ Vitrification media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- Vitrification Media(VS solution) — KITAZATO CORPORATION · Class II
- TS(Thawing Solution) Pack 4 vials — KITAZATO CORPORATION · Class II
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
- Origio A/S
Sources (1)
- FDA UDI 77c123be-ab4a-4d4d-a8df-6ba8093dadfc 34 fields · synced Jun 1, 2026