Identity
- Trade Name
- SPERM WASH MEDIUM FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. FDA UDI
- Model / Reference
- 2003 FDA UDI
- Description
- SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. FDA UDI
Identifiers
- Catalog Number
- 2003 FDA UDI
- Primary DI / UDI-DI
- 10859268006043 FDA UDI
- 510(k) Number
- K000989 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: IVF medium
Sperm Wash Medium by Invitrocare, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K000989 also covers:
- SPERM WASH MEDIUM — INVITROCARE, INCORPORATED
- SPERM WASH MEDIUM — INVITROCARE, INCORPORATED
- SPERM WASH MEDIUM — INVITROCARE, INCORPORATED
- SPERM WASH MEDIUM — INVITROCARE, INCORPORATED
- SPERM WASH MEDIUM — INVITROCARE, INCORPORATED
- SPERM WASH MEDIUM — INVITROCARE, INCORPORATED
- SPERM WASH MEDIUM for Swim-Up — INVITROCARE, INCORPORATED
- SPERMCARE / SPERM WASH - Gradient System — INVITROCARE, INCORPORATED
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
- Invitrocare, Incorporated
Sources (1)
- FDA UDI c7b86d98-06b1-44cc-985b-abcc5ac834d0 35 fields · synced May 30, 2026