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A Series, Sys One, Heater Hum

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name
A Series, Sys One, Heater Hum FDA UDI
Generic Name
Heated respiratory humidifier FDA UDI
Device Name
A Series System One Heated Humidifier, Italy FDA UDI
Model / Reference
00 FDA UDI
Description
A Series System One Heated Humidifier, Italy FDA UDI

Identifiers

Catalog Number
IT1111552 FDA UDI
Primary DI / UDI-DI
00606959048720 FDA UDI
FDA Product Code
MNS FDA UDI
MNT FDA UDI
GMDN Term
Heated respiratory humidifier FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 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: Heated respiratory humidifier

A Series, Sys One, Heater Hum by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heated respiratory humidifier.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA UDI 1911e25f-a405-4895-a7a2-fab03673da9c 35 fields · synced Jun 1, 2026