Identity
- Trade Name
- Hokanson FDA UDI
- Generic Name
- Blood pressure cuff inflator, electronic FDA UDI
- Device Name
- Calculating Cuff Inflator-Data Link Version - A portable cuff inflator with an electronic memory and calculator used to measure segmental limb systolic pressures and calculate pressure indices. Inflation and deflation are controlled by the clinician. Measured pressure readings can be stored in memory registers of the device, or sent directly to a computer. The instrument is powered by rechargeable batteries. FDA UDI
- Model / Reference
- TD312DL FDA UDI
- Description
- Calculating Cuff Inflator-Data Link Version - A portable cuff inflator with an electronic memory and calculator used to measure segmental limb systolic pressures and calculate pressure indices. Inflation and deflation are controlled by the clinician. Measured pressure readings can be stored in memory registers of the device, or sent directly to a computer. The instrument is powered by rechargeable batteries. FDA UDI
Identifiers
- Catalog Number
- 00939 FDA UDI
- Primary DI / UDI-DI
- 00817065022423 FDA UDI
- 510(k) Number
- K842067 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Blood pressure cuff inflator, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff inflator, electronic
Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff inflator, electronic.
- Hokanson — D. E. Hokanson, Inc. · Class II
Cleared under the same submission
K842067 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
- D. E. Hokanson, Inc.
Sources (1)
- FDA UDI 716e20a6-8ce4-49b3-bc6c-b8dd26719df4 36 fields · synced Jun 8, 2026