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MGC Diagnostics

FDA UDI

Class II (US FDA UDI)

by Medical Graphics Corp.

Identity

Trade Name
MGC Diagnostics FDA UDI
Generic Name
Whole-body plethysmograph FDA UDI
Device Name
Elite Platinum DX FDA UDI
Model / Reference
830005-002 FDA UDI
Description
Elite Platinum DX FDA UDI

Identifiers

Catalog Number
830005-002 FDA UDI
Primary DI / UDI-DI
00810016250418 FDA UDI
510(k) Number
K943259 FDA UDI
FDA Product Code
CCM FDA UDI
GMDN Term
Whole-body plethysmograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1750 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Whole-body plethysmograph

MGC Diagnostics by Medical Graphics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Whole-body plethysmograph.

Cleared under the same submission

K943259 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Graphics Corp.

Sources (1)

  • FDA UDI 5121206d-2636-4929-8c6b-c85c5f217263 35 fields · synced May 30, 2026