Identity
- Trade Name
- Sperm Fridge FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- 1 Packs FDA UDI
- Model / Reference
- Sperm Fridge FDA UDI
- Description
- 1 Packs FDA UDI
Identifiers
- Catalog Number
- 92205 FDA UDI
- Primary DI / UDI-DI
- 04582231465736 FDA UDI
- 510(k) Number
- K192845 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
No
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
Category: IVF medium
Sperm Fridge by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as IVF medium.
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- CaseBioscience® — Casebioscience, Inc. · Class II
- SpermFreeze SSP — Fertipro NV · Class II
- Gems Blastocyst Medium — GENEA BIOMEDX PTY LTD · Class II
- Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
Cleared under the same submission
K192845 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
- Kitazato Corporation
Sources (1)
- FDA UDI 69121d75-560f-4dbf-ac01-625efaff19b1 36 fields · synced Jun 8, 2026