← Back to catalogue

Bioflux

FDA UDI

Class II (US FDA UDI)

by Biotricity, Inc.

Identity

Trade Name
BIOFLUX FDA UDI
Generic Name
Electrocardiography telemetric monitoring system transmitter FDA UDI
Model / Reference
1.0 FDA UDI

Identifiers

Primary DI / UDI-DI
B635BIOFLUX100 FDA UDI
510(k) Number
K172311 FDA UDI
FDA Product Code
DXH FDA UDI
GMDN Term
Electrocardiography telemetric monitoring system transmitter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2920 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiography telemetric monitoring system transmitter

Bioflux by Biotricity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiography telemetric monitoring system transmitter.

Cleared under the same submission

K172311 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biotricity, Inc.

Sources (1)

  • FDA UDI 4e902b39-b065-4703-92cf-59861d26300a 33 fields · synced Jun 8, 2026