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: CPAP/BPAP face mask, reusable FDA UDI
Device Name: Solo Nasal Mask Fit Pack Sleep Lab A FDA UDI
Model / Reference: SLN1SMLSLA FDA UDI
Description: Solo Nasal Mask Fit Pack Sleep Lab A FDA UDI

Identifiers

Catalog Number: SLN1SMLSLA FDA UDI
Primary DI / UDI-DI: 09420012472755 FDA UDI
510(k) Number: K223696 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: CPAP/BPAP face mask, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: CPAP/BPAP face mask, reusable

Fisher & Paykel Healthcare's Solo Nasal Mask Fit Pack Sleep Lab A is a versatile and reliable CPAP/BiPPA face mask for patients in need of continuous positive airway pressure or bi-level positive airway pressure therapy. This reusable device features a flexible design, adjustable seal, and a headstrap to ensure a comfortable fit. With its durable construction and user-friendly interface, it's an excellent choice for individuals seeking effective respiratory treatment.

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Also classified as CPAP/BPAP face mask, reusable.

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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

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Manufacturer

Manufacturer: Fisher & Paykel Healthcare, Inc.

Sources (1)

FDA UDI 5f200381-0791-4f74-af8f-12c77d9a3f71 38 fields · synced Jun 22, 2026

Fisher & Paykel Healthcare

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)