Identity
- Trade Name
- NIBP cuff EUDAMEDOrantech FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP cuff EUDAMEDWith inflation bag, Single tube, With connector Adult Range 23-33cm FDA UDI
- Model / Reference
- BP-50BS-W01M EUDAMEDFDA UDI
- Description
- With inflation bag, Single tube, With connector Adult Range 23-33cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970706368435 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH06QZ EUDAMED
- 510(k) Number
- K173197 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Orantech by Orantech Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
Sources (2)
- FDA UDI e9fad303-8cf6-425c-9167-bf733e03b434 34 fields · synced Jun 18, 2026
- EUDAMED 8d7bbb94-a07e-40a6-8347-cb0ce1bcecfc 61 fields · synced Jun 18, 2026