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Mistic

FDA UDI

Class II (US FDA UDI)

by Pegasus Research Corp.

Identity

Trade Name
MISTIC FDA UDI
Generic Name
Nebulizing adaptor FDA UDI
Device Name
ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT FDA UDI
Model / Reference
P3000NAL FDA UDI
Description
ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT FDA UDI

Identifiers

Catalog Number
P3000NAL FDA UDI
Primary DI / UDI-DI
00612223300357 FDA UDI
510(k) Number
K893942 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Nebulizing adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 2.5 Inch FDA UDI
Height — 3.5 Inch FDA UDI
Length — 14.5 Inch FDA UDI

Category: Nebulizing adaptor

Mistic by Pegasus Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing adaptor.

Cleared under the same submission

K893942 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pegasus Research Corp.

Sources (1)

  • FDA UDI f5fa1696-f5a4-40a7-b772-16229fbf0f1f 36 fields · synced May 30, 2026