Identity
- Trade Name
- VIT KIT - Warm NX FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- VIT KIT - Warm NX FDA UDI
- Model / Reference
- 90183 FDA UDI
- Description
- VIT KIT - Warm NX FDA UDI
Identifiers
- Catalog Number
- 90183 FDA UDI
- Primary DI / UDI-DI
- 00857515006313 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
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
Category: IVF medium kit
VIT KIT - Warm NX by Fujifilm Irvine Scientific, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as IVF medium kit.
- Vitrification Media(BS solution) — KITAZATO CORPORATION · Class II
- G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- ORIGIO Gradient 40/80 — Origio A/S · Class II
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
Sources (2)
- FDA UDI bab6ecc0-1bec-4cf1-9ca8-60788a4e93ff 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026