Identity
- Trade Name
- LabTron FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Standard Sphygmomanometer FDA UDI
- Model / Reference
- 165NBL FDA UDI
- Description
- Standard Sphygmomanometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- M368165NBL1 FDA UDI
- 510(k) Number
- K092245 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aneroid manual sphygmomanometer
LabTron by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aneroid manual sphygmomanometer.
- Diagnostix™ — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- e-mega® black, disinfectable one-piece cuff, small adult size 2-tube — Rudolf Riester GmbH & Co. KG · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Princess — American Diagnostic Corporation · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- E-sphyg™ — American Diagnostic Corporation · Class II
- BAUM — W.A. BAUM CO., INC. · Class II
Cleared under the same submission
K092245 also covers:
- Blood Pressure Kit — Dynarex Corp.
- LABTRON — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, 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
- GF Health Products, Inc
Sources (1)
- FDA UDI 861446d0-b093-46f2-82d7-f46e0299ab04 36 fields · synced May 30, 2026