Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Electronic thermometer probe cover FDA UDI
- Device Name
- SHEATH,THERM,RECTAL,DIGITL,PRELUB,3600 FDA UDI
- Model / Reference
- MDS9604CS FDA UDI
- Description
- SHEATH,THERM,RECTAL,DIGITL,PRELUB,3600 FDA UDI
Identifiers
- Catalog Number
- MDS9604CS FDA UDI
- Primary DI / UDI-DI
- 10193489012453 FDA UDI
- 510(k) Number
- K161299 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Electronic thermometer probe 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic thermometer probe cover
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161299 also covers:
- microdot® Pro Control Solution — Cambridge Sensors USA, LLC.
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- microdot® Pro Test Strips (25ct) — Cambridge Sensors USA, LLC.
- microdot® Pro Test Strips (50ct) — Cambridge Sensors USA, LLC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 9f70630a-88ba-4c50-9686-d6c82622efa4 36 fields · synced May 30, 2026