Cardiovascular Procedure Kit (UDI 76212-01)
Manufactured by Terumo Cardiovascular Systems Corporation
Device Regulatory Overview
The Cardiovascular Procedure Kit (Model/Catalog Number: 76212-01) is a medical device manufactured by Terumo Cardiovascular Systems Corporation. This product is indexed under FDA Product Code / Category Classification within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit...
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754...
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 ...
Technical Specifications
- Model Number
- 76212-01
- Product Code / EMDN
- N/A
- Device Name
- Database Sync Date
- 2026-08-09 09:04:15
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Cardiovascular Procedure Kit?
The registered manufacturer of record for Cardiovascular Procedure Kit is Terumo Cardiovascular Systems Corporation.
What is the Primary UDI-DI identifier for Cardiovascular Procedure Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 76212-01.
What classification code is assigned to this device?
This device is registered under product classification code .
Similar Classification Devices ()
Other Devices by Terumo Cardiovascular Systems Corporation
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint