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BioSticker™ System Offload Software

FDA UDI

Class II (US FDA UDI)

by Biointellisense Inc.

Identity

Trade Name
BioSticker™ System Offload Software FDA UDI
Generic Name
Electrocardiography telemetric monitoring system transmitter FDA UDI
Device Name
Offload Software for the BioSticker System. FDA UDI
Model / Reference
SWDT10001-1.1.1 FDA UDI
Description
Offload Software for the BioSticker System. FDA UDI

Identifiers

Primary DI / UDI-DI
00850005949046 FDA UDI
510(k) Number
K191614 FDA UDI
FDA Product Code
DRG FDA UDI
NDC FDA UDI
GMDN Term
Electrocardiography telemetric monitoring system transmitter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 FDA UDI
868.1890 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

BioSticker™ System Offload Software by Biointellisense 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

K191614 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biointellisense Inc.

Sources (1)

  • FDA UDI c9a76793-f366-4b78-a4a4-262c86da6f17 34 fields · synced Sep 18, 2026