Identity
- Trade Name
- Orantech FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- TPU, Double tube, Neonatal #4 Range 7-13cm FDA UDI
- Model / Reference
- BPD-14TD FDA UDI
- Description
- TPU, Double tube, Neonatal #4 Range 7-13cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970706369999 FDA UDI
- 510(k) Number
- K173197 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Blood pressure cuff, single-use 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood pressure cuff, single-use
Orantech by Orantech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (1)
- FDA UDI 6e1d2c3c-7062-4f4d-aafe-bbc76122cd0a 34 fields · synced Jun 1, 2026