← Back to catalogue

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
Waterbag (2 Pack) FDA UDI
Model / Reference
900PT401 FDA UDI
Description
Waterbag (2 Pack) FDA UDI

Identifiers

Catalog Number
900PT401 FDA UDI
Primary DI / UDI-DI
09420012422859 FDA UDI
510(k) Number
K131895 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

K131895 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Fisher & Paykel Healthcare, Inc.

Sources (1)

  • FDA UDI 80144f64-90bd-4d46-a805-20a1148cdc1c 37 fields · synced Jun 6, 2026