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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
Pulmonary function analysis system, adult FDA UDI
Device Name
Ultima System PF - 120V UPS FDA UDI
Model / Reference
800820-011 FDA UDI
Description
Ultima System PF - 120V UPS FDA UDI

Identifiers

Catalog Number
800820-011 FDA UDI
Primary DI / UDI-DI
B368800820011 FDA UDI
510(k) Number
K061731 FDA UDI
FDA Product Code
BZL FDA UDI
GMDN Term
Pulmonary function analysis system, adult FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1730 FDA UDI
Commercial Distribution
Not 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

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

Cleared under the same submission

K061731 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 5ad253a0-1fb7-4db3-9a47-fdf19b370cab 36 fields · synced May 30, 2026