Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Home-use blood glucose spot-check system FDA UDI
- Device Name
- GLUCOSE TEST STRIP WITH PURPLE COLOR FDA UDI
- Model / Reference
- 5059 FDA UDI
- Description
- GLUCOSE TEST STRIP WITH PURPLE COLOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479212784 FDA UDI
- 510(k) Number
- K092052 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Home-use blood glucose spot-check system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
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: Home-use blood glucose spot-check system
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use blood glucose spot-check system.
- D-Care — HUDSON SCIENTIFIC LLC · Class II
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- AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT — GERMAINE LABORATORIES, INC. · Class II
- VivaGuard Ino Blood Glucose Test Strips — ABOUND Diagnostics, Inc · Class II
- D-Care — HUDSON SCIENTIFIC LLC · Class II
- AIMSTRIP PLUS LANCETS — GERMAINE LABORATORIES, INC. · Class II
- D-Care — HUDSON SCIENTIFIC LLC · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Cleared under the same submission
K092052 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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI ce5009d5-4379-46ee-b693-9935781f28e9 34 fields · synced May 31, 2026