Identity
- Trade Name
- RedDrop One FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- The RedDrop One is a single use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples. FDA UDI
- Model / Reference
- 300-25-010 FDA UDI
- Description
- The RedDrop One is a single use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011954064 FDA UDI
- 510(k) Number
- K234081 FDA UDI
- FDA Product Code
- FMK FDA UDI
- GMDN Term
- Manual blood lancing device, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 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
Radiation Sterilization FDA UDI
Category: Manual blood lancing device, single-use
RedDrop One by Reddrop DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K234081 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
- Reddrop DX
Sources (1)
- FDA UDI 8fd9b75e-2049-4ba3-ab3a-d76e8a835523 34 fields · synced Jun 1, 2026