Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Device Name
- Thermodilution Balloon Catheter FDA UDI
- Model / Reference
- IPN000108 FDA UDI
- Description
- Thermodilution Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- AI-07377-NH FDA UDI
- Primary DI / UDI-DI
- 00801902008725 FDA UDI
- 510(k) Number
- K833918 FDA UDI
- FDA Product Code
- DYG FDA UDI
- GMDN Term
- Pulmonary artery balloon catheter, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1240 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
Yes
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
Dimensions & Sizes
- Size
- Length — 110 Centimeter FDA UDICatheter Gauge — 7.5 French FDA UDI
Category: Pulmonary artery balloon catheter, electrical
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary artery balloon catheter, electrical.
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- Thermodilution Catheter and Accessories — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
- SWAN-GANZ — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K833918 also covers:
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
- Teleflex Incorporated
Sources (1)
- FDA UDI caa9ba68-56fe-49f6-a4d7-366aef955126 38 fields · synced May 31, 2026