Identity
- Trade Name
- NIBP cuff EUDAMEDOrantech FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- NIBP cuff EUDAMEDTPU, Single tube, With connector Neonatal #2 Range 4-8cm FDA UDI
- Model / Reference
- BPD-12TS-W05 EUDAMEDBPD-12TS-W05P FDA UDI
- Description
- TPU, Single tube, With connector Neonatal #2 Range 4-8cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691900368 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, single-use 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
Yes
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
Orantech by Orantech Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
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
- Orantech Inc.
Sources (2)
- FDA UDI 8a127828-3dc5-43f4-8b18-f29baff7be54 34 fields · synced Oct 7, 2026
- EUDAMED 34bc7ede-e2e9-4d29-a4e1-be2545ac946e 61 fields · synced Jul 11, 2026