Identity
- Trade Name
- Washing Solution Add-On Pack FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Washing Solution Add-On Pack. Contains 6x2mL Thawing Solution-TS to be used with Vit-Kit Thaw. FDA UDI
- Model / Reference
- 90136-TPACK FDA UDI
- Description
- Washing Solution Add-On Pack. Contains 6x2mL Thawing Solution-TS to be used with Vit-Kit Thaw. FDA UDI
Identifiers
- Catalog Number
- 90136-TPACK FDA UDI
- Primary DI / UDI-DI
- 00810195240453 FDA UDI
- 510(k) Number
- K160006 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
Category: IVF medium
Washing Solution Add-On Pack by Irvine Scientific, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160006 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
- Irvine Scientific, Llc
Sources (1)
- FDA UDI 1a2cc940-adf7-4135-80d0-1f75fe155780 36 fields · synced May 30, 2026