Identity
- Trade Name
- ViaMed FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Deluxe chrome palm aneroid gauge, 300mm HG gauge. Deluxe Calibrated nylon cuff with velcro an ddurable latex bladder. Complete unit is packed in a carrying case. FDA UDI
- Model / Reference
- 13312-BLUE FDA UDI
- Description
- Deluxe chrome palm aneroid gauge, 300mm HG gauge. Deluxe Calibrated nylon cuff with velcro an ddurable latex bladder. Complete unit is packed in a carrying case. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811382010774 FDA UDI
- 510(k) Number
- K043286 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Blood pressure cuff, reusable 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
Yes
FDA UDI
Category: Blood pressure cuff, reusable
ViaMed by Rece International Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K043286 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
- Rece International Corp.
Sources (1)
- FDA UDI ab2fef63-80ce-44d5-90ee-e5bbcc39d547 35 fields · synced May 30, 2026