Identity
- Trade Name
- MetriQ™ Irrigation Tubing Set FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Device Name
- Open-Irrigation Tubing Set FDA UDI
- Model / Reference
- M0041170 FDA UDI
- Description
- Open-Irrigation Tubing Set FDA UDI
Identifiers
- Catalog Number
- M0041170 FDA UDI
- Primary DI / UDI-DI
- 08714729862208 FDA UDI
- PMA Number
- P150005 FDA UDI
- FDA Product Code
- OAD FDA UDI
- GMDN Term
- Cardiac ablation system irrigation tubing set FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac ablation system irrigation tubing set
MetriQ™ Irrigation Tubing Set by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac ablation system irrigation tubing set.
- INTELLAGEN™ Tubing Set 40 PK — Stockert GmbH · Class III
- Arthrex® — Arthrex, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class II
- Cool Point™ — IRVINE BIOMEDICAL, INC. · Class III
- DiamondTemp™ Irrigation Tubing Set — MEDTRONIC, INC. · Class III
- AVANOS — Avanos Medical, Inc. · Class II
- CoolFlow — Biosense Webster Inc · Class II
Cleared under the same submission
P150005 also covers:
- Blazer® Open-Irrigated — Boston Scientific
- Blazer® Open-Irrigated — Boston Scientific
- Blazer® Open-Irrigated — Boston Scientific
- Blazer® Open-Irrigated — Boston Scientific
- INTELLANAV STABLEPOINT™ — Boston Scientific
- INTELLANAV STABLEPOINT™ — Boston Scientific
- IntellaNav MiFi™ Open-Irrigated — Boston Scientific
- IntellaNav MiFi™ Open-Irrigated — Boston Scientific
- IntellaNav MiFi™ Open-Irrigated — Boston Scientific
- IntellaNav™ Open-Irrigated — Boston Scientific
- IntellaNav™ Open-Irrigated — Boston Scientific
- IntellaNav™ Open-Irrigated — Boston Scientific
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 7c09fba0-f1d5-4acf-a7a5-31f50dddaada 35 fields · synced May 31, 2026