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BresoDX1 Master Kit

FDA UDI

Class II (US FDA UDI)

by Bresotec, Inc.

Identity

Trade Name
BresoDX1 Master Kit FDA UDI
Generic Name
Home-use sleep apnoea recording system FDA UDI
Device Name
Contains Main Kit, Accessory Kit, and Nonin Pulse Oximeter, USA only FDA UDI
Model / Reference
BTSM1US FDA UDI
Description
Contains Main Kit, Accessory Kit, and Nonin Pulse Oximeter, USA only FDA UDI

Identifiers

Primary DI / UDI-DI
00990008600077 FDA UDI
510(k) Number
K220012 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Home-use sleep apnoea recording system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Home-use sleep apnoea recording system

BresoDX1 Master Kit by Bresotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use sleep apnoea recording system.

Cleared under the same submission

K220012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bresotec, Inc.

Sources (1)

  • FDA UDI 1cd44e49-5c62-4612-a1e4-56726c17d890 34 fields · synced May 30, 2026