NeoPAP Mask - S

FDA UDI

Class II (US FDA UDI)

by Circadiance

Identity

Trade Name: NeoPAP Mask - S FDA UDI
Generic Name: Neonatal CPAP unit FDA UDI
Device Name: NeoPAP Mask - S FDA UDI
Model / Reference: 1078667 FDA UDI
Description: NeoPAP Mask - S FDA UDI

Identifiers

Catalog Number: 1078667 FDA UDI
Primary DI / UDI-DI: B0361078667 FDA UDI
510(k) Number: K103410 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Neonatal CPAP unit 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Neonatal CPAP unit

NeoPAP Mask - S by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neonatal CPAP unit.

NeoPAP Bonnet - M — Circadiance · Class II
NeoPAP Device - US — Circadiance · Class II
NeoPAP Cannula - XS — Circadiance · Class II
NeoPAP Cannula - L — Circadiance · Class II
NeoPAP Bonnet - S — Circadiance · Class II
NeoPAP Cannula - S — Circadiance · Class II
NeoPAP Mask - L — Circadiance · Class II
NeoPAP Delivery Circuit Adapter & Sizing Chart — Circadiance · Class II

Cleared under the same submission

K103410 also covers:

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: Circadiance

Sources (1)

FDA UDI 7b51fd54-edba-4229-8754-9fadbbd1d23c 36 fields · synced Jun 9, 2026