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Futuremed

FDA UDI

Class II (US FDA UDI)

by Futuremed America, Inc.

Identity

Trade Name
FUTUREMED FDA UDI
Generic Name
Diagnostic spirometer, professional FDA UDI
Device Name
SPIROVISION PC BASED SPIROMETER FDA UDI
Model / Reference
SpiroVision FDA UDI
Description
SPIROVISION PC BASED SPIROMETER FDA UDI

Identifiers

Primary DI / UDI-DI
00853452007024 FDA UDI
510(k) Number
K020745 FDA UDI
FDA Product Code
BZG FDA UDI
BTY FDA UDI
BZC FDA UDI
GMDN Term
Diagnostic spirometer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 FDA UDI
868.1890 FDA UDI
868.1880 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

No

FDA UDI

Category: Diagnostic spirometer, professional

Futuremed by Futuremed America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic spirometer, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Futuremed America, Inc.

Sources (1)

  • FDA UDI b3122f21-5b1a-4c1c-a06f-10c1cf807997 35 fields · synced May 30, 2026