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FDA product code QFJ

Intravascular Bleed Monitor

CardiovascularClass 221 CFR 870.1345
Verified
US regulatory classifications
US Product Code (FDA)
QFJ
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.1345
View CFR Regulation
Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

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01Bleed monitor02Intravascular monitor03Hemorrhage detection04Blood loss05Internal bleeding06Vascular monitor07Patient safety08Diagnostic monitor09Blood monitoring10Medical sensor
About this record

Intravascular Bleed Monitor is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.