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Fisher & Paykel Healthcare

FDA UDI

Class II (US FDA UDI)

by Fisher & Paykel Healthcare, Inc.

Identity

Trade Name
Fisher & Paykel Healthcare FDA UDI
Generic Name
Inspiratory line humidification chamber, reusable FDA UDI
Device Name
Reusable humidification chamber FDA UDI
Model / Reference
MR340E FDA UDI
Description
Reusable humidification chamber FDA UDI

Identifiers

Catalog Number
MR340E FDA UDI
Primary DI / UDI-DI
09420012401588 FDA UDI
510(k) Number
K913368 FDA UDI
FDA Product Code
BTT FDA UDI
GMDN Term
Inspiratory line humidification chamber, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5450 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

Yes

FDA UDI

Category: Inspiratory line humidification chamber, reusable

Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inspiratory line humidification chamber, reusable.

Cleared under the same submission

K913368 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fisher & Paykel Healthcare, Inc.

Sources (1)

  • FDA UDI 70bd6186-b718-407d-a1e5-9763d7bbdfac 36 fields · synced Jun 1, 2026