Identity
- Trade Name
- Walgreens FDA UDI
- Generic Name
- Natural conception assistance kit FDA UDI
- Device Name
- Digital Ovulation Predictor - 7 Tests with Insert FDA UDI
- Model / Reference
- Multi-Use Digital MidStream 6 FDA UDI
- Description
- Digital Ovulation Predictor - 7 Tests with Insert FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00311917198873 FDA UDI
- 510(k) Number
- K951538 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
Dimensions & Sizes
- Size
- Height — 83 Millimeter FDA UDI
Category: Natural conception assistance kit
Walgreens by Walgreen Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Natural conception assistance kit.
- Dr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS LLC · Class I
- Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATION · Class II
- Topcare — Topco Associates, LLC · Class I
- PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd. · Class I
- DAVID — Equinox Biotech Co., Ltd. · Class I
- Smilereader ovulation test kit — Equinox Biotech Co., Ltd. · Class I
- Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
Cleared under the same submission
K951538 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Walgreen Co.
Sources (1)
- FDA UDI 2cf93fbc-4be1-4f75-85fd-2a468b37b710 37 fields · synced Jun 8, 2026