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Thermagard

FDA UDI

Class II (US FDA UDI)

by Pegasus Research Corp.

Identity

Trade Name
THERMAGARD FDA UDI
Generic Name
Therapeutic agent vaporizer, benchtop FDA UDI
Device Name
NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER FDA UDI
Model / Reference
5705 FDA UDI
Description
NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER FDA UDI

Identifiers

Catalog Number
P20001H FDA UDI
Primary DI / UDI-DI
00612223057053 FDA UDI
510(k) Number
K880473 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Therapeutic agent vaporizer, benchtop 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

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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 4.5 Inch FDA UDI
Weight — 3 Pound FDA UDI
Outer Diameter — 4 Inch FDA UDI

Category: Therapeutic agent vaporizer, benchtop

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

Similar devices

Also classified as Therapeutic agent vaporizer, benchtop.

Cleared under the same submission

K880473 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 c91a2c92-9053-4c78-a047-847188051a07 36 fields · synced May 30, 2026