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Perfect Fit

FDA UDI

Class II (US FDA UDI)

by Dymedix Diagnostics, Inc.

Identity

Trade Name
Perfect Fit FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
FastTrack Demo Kit, Adult, Alice 6 FDA UDI
Model / Reference
18-01019-0601 FDA UDI
Description
FastTrack Demo Kit, Adult, Alice 6 FDA UDI

Identifiers

Primary DI / UDI-DI
00817377022258 FDA UDI
510(k) Number
K040605 FDA UDI
FDA Product Code
BZQ FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 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: Polysomnograph

Perfect Fit by Dymedix Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnograph.

Cleared under the same submission

K040605 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dymedix Diagnostics, Inc.

Sources (1)

  • FDA UDI a3d85885-cb06-400e-ad7f-d68975385f28 34 fields · synced May 30, 2026