DreamMapper

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: DreamMapper FDA UDI
Generic Name: Self-care monitoring/reporting software FDA UDI
Device Name: DreamMapper App iOS (APAC) FDA UDI
Model / Reference: DreamMapper App iOS, Asia-Pacific Instance - 2 FDA UDI
Description: DreamMapper App iOS (APAC) FDA UDI

Identifiers

Catalog Number: 1127959 FDA UDI
Primary DI / UDI-DI: 00606959057715 FDA UDI
FDA Product Code: MNS FDA UDI
BZD FDA UDI
MNT FDA UDI
GMDN Term: Self-care monitoring/reporting software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Self-care monitoring/reporting software

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

Similar devices

Also classified as Self-care monitoring/reporting software.

MiniMed™ Mobile — MEDTRONIC MINIMED, INC. · Class II
Floodlight MS Draw Shape Test — Roche Molecular Systems, Inc. · Class I
Floodlight MS Cognitive Test — Roche Molecular Systems, Inc. · Class II
Irregular Rhythm Notifications — APPLE INC. · Class II
Samsung ECG Monitor App with Irregular Heart Rhythm Notification — Samsung Electronics Co., Ltd. · Class II
myoncare — ONCARE GmbH · Class I
Sugarmate, Mac Glance Application — Sugarmate, LLC · Class I
CareLink™ Personal — MEDTRONIC MINIMED, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Respironics, Inc.

Sources (1)

FDA UDI cac8026a-f703-4f2a-aecd-afa6e8e24a9f 34 fields · synced Jun 8, 2026