Identity
- Trade Name
- Orantech FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Dark blue nylon, Bladderless, Single tube, With connector Small Adult Range 20.5-28.5cm FDA UDI
- Model / Reference
- BPN-40ND-W1011 FDA UDI
- Description
- Dark blue nylon, Bladderless, Single tube, With connector Small Adult Range 20.5-28.5cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691974291 FDA UDI
- 510(k) Number
- K173197 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Blood pressure cuff, reusable
A comprehensive medical device directory listing the Orantech Blood Pressure Cuff, a reusable and inelastic sleeve device used for monitoring blood pressure. This device is wrapped around the upper arm or leg of the patient and has one or two connecting tubes with locking connectors that can be connected to a sphygmomanometer or patient monitoring system.
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orbit-K — SUNTECH MEDICAL, INC. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K173197 also covers:
- GE Compatible Adult NIBP Hose, 8 ft, Dual, Female Threaded BP09 Connectors — CABLES AND SENSORS, LLC
- GE Compatible NIBP Double Hose OEM 107363 — CABLES AND SENSORS, LLC
- GE Dinamap NIBP Hose: Adult NIBP Hose — CABLES AND SENSORS, LLC
- Zoll Compatible NIBP Hose - 8000-0655 — CABLES AND SENSORS, LLC
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
- Orantech — Orantech Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Orantech Inc.
Sources (1)
- FDA UDI 8e5c767c-35ba-45a6-bfd8-b75e5ebcf96c 34 fields · synced Jul 15, 2026