MGC Diagnostics

FDA UDI

Class I (US FDA UDI)

by Medical Graphics Corp.

Identity

Trade Name: MGC Diagnostics FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: GAS DLCO (RTD) 0.3%CO, 0.3%CH4, 21%O2, BAL N2 FDA UDI
Model / Reference: 536057-001 FDA UDI
Description: GAS DLCO (RTD) 0.3%CO, 0.3%CH4, 21%O2, BAL N2 FDA UDI

Identifiers

Catalog Number: 536057-001 FDA UDI
Primary DI / UDI-DI: 00810016251552 FDA UDI
FDA Product Code: BXK FDA UDI
GMDN Term: Pulmonary function analysis system, adult FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.6400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary function analysis system, adult

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

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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 I	Pending data

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Manufacturer

Manufacturer: Medical Graphics Corp.

Sources (1)

FDA UDI 3591d8d6-b7b7-43d0-b39d-b953961b9ffb 34 fields · synced May 30, 2026