Identity
- Trade Name
- MEDLINE INDUSTRIES, INC. FDA UDI
- Generic Name
- Capillary thermometer cover FDA UDI
- Device Name
- STRIP, GLUCOSE, FOIL, G3, PROF.USE ONLY FDA UDI
- Model / Reference
- MPH3550FL FDA UDI
- Description
- STRIP, GLUCOSE, FOIL, G3, PROF.USE ONLY FDA UDI
Identifiers
- Catalog Number
- MPH3550FL FDA UDI
- Primary DI / UDI-DI
- 10888277365940 FDA UDI
- 510(k) Number
- K120448 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Capillary thermometer cover 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
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: Capillary thermometer cover
Medline Industries, Inc. by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K120448 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 2d489694-e7f4-4b07-be28-506307a6a487 37 fields · synced Jun 7, 2026