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Water for Assisted Reproductive Technologies (A.R.T.) Use
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Water for Assisted Reproductive Technologies (A.R.T.) Use FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Water for Assisted Reproductive Technologies (A.R.T.) Use FDA UDI
- Model / Reference
- 9307-1L FDA UDI
- Description
- Water for Assisted Reproductive Technologies (A.R.T.) Use FDA UDI
Identifiers
- Catalog Number
- 9307 FDA UDI
- Primary DI / UDI-DI
- 00893727002880 FDA UDI
- 510(k) Number
- K011598 FDA UDI
- FDA Product Code
- MTW FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6170 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Liter FDA UDI
Category: IVF medium
Water for Assisted Reproductive Technologies (A.R.T.) Use by Fujifilm Irvine Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as IVF medium.
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Cleared under the same submission
K011598 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
- Fujifilm Irvine Scientific, Inc.
Sources (1)
- FDA UDI 5e643a41-3284-4d5e-ba81-38ab7d29bc34 38 fields · synced May 30, 2026