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McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Diagnostic spirometer, professional FDA UDI
Device Name
SPIROMETER, W/O CRADLE/PRINTER FDA UDI
Model / Reference
786 FDA UDI
Description
SPIROMETER, W/O CRADLE/PRINTER FDA UDI

Identifiers

Primary DI / UDI-DI
20612479194407 FDA UDI
510(k) Number
K993921 FDA UDI
FDA Product Code
BZG FDA UDI
GMDN Term
Diagnostic spirometer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic spirometer, professional

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic spirometer, professional.

Cleared under the same submission

K993921 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mckesson Medical-Surgical Inc.

Sources (1)

  • FDA UDI 14aa01b2-8f5c-4eae-b592-85d383dc2e1f 34 fields · synced Jun 8, 2026