Identity
- Trade Name
- H.E.B FDA UDI
- Generic Name
- Natural conception assistance kit FDA UDI
- Device Name
- H.E.B One Step Ovulation Predictor FDA UDI
- Model / Reference
- One Step Ovulation Predictor FDA UDI
- Description
- H.E.B One Step Ovulation Predictor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00041220524426 FDA UDI
- 510(k) Number
- K002867 FDA UDI
- FDA Product Code
- CEP FDA UDI
- GMDN Term
- Natural conception assistance kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Natural conception assistance kit
H.e.b by H. E. Butt Grocery Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- H. E. Butt Grocery Company
Sources (1)
- FDA UDI acda6ef2-112e-4859-8526-f6b9848b7cd4 36 fields · synced Jun 8, 2026