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REMstar System One 60 Series

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
REMstar System One 60 Series FDA UDI
Generic Name
Home CPAP unit FDA UDI
Device Name
REMstar Auto A-Flex with Heated Tube Humidifier System One 60 Series, Japan FDA UDI
Model / Reference
REMstar Auto A-Flex w/HT Humid System One 60 Series JP FDA UDI
Description
REMstar Auto A-Flex with Heated Tube Humidifier System One 60 Series, Japan FDA UDI

Identifiers

Catalog Number
JP566TS FDA UDI
Primary DI / UDI-DI
00606959030954 FDA UDI
510(k) Number
K113068 FDA UDI
FDA Product Code
BZD FDA UDI
GMDN Term
Home CPAP unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
Not 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

REMstar System One 60 Series by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K113068 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI 883a5460-38d0-4f85-850a-efd5b07a2fdf 38 fields · synced Jun 8, 2026