Identity
- Trade Name
- MEK Compatible NIBP Hose FDA UDI
- Generic Name
- Invasive blood pressure monitoring tubing set FDA UDI
- Model / Reference
- AS-09-090 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B817AS090900 FDA UDI
- 510(k) Number
- K173197 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Invasive blood pressure monitoring tubing set 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
No
FDA UDI
Prescription Use
Yes
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: Invasive blood pressure monitoring tubing set
MEK Compatible NIBP Hose by Cables And Sensors, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive blood pressure monitoring tubing set.
- EASY VENT(TM) EDE-001 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- NAMIC — NAVILYST MEDICAL, INC. · Class I
- CRITIFLO(TM) TA4004 (3ML/HR) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- COMP PRLINE MF 80 IN (200CM) CLR — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- NAMIC — MEDLINE INDUSTRIES, INC. · Class I
- Connecting Tube — Tianck Medical Co., Ltd. · Class II
- NAMIC — NAVILYST MEDICAL, INC. · Class I
- COMP PRLINE MM 100CM CLR — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cables And Sensors, Llc
Sources (1)
- FDA UDI 789dd9f6-77ab-4078-b338-d2c6a16c464f 33 fields · synced May 30, 2026