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Spiro Handle

FDA UDI

Class II (US FDA UDI)

by Bionet Company, Ltd.

Identity

Trade Name
Spiro Handle FDA UDI
Generic Name
Diagnostic spirometer, professional FDA UDI
Device Name
SPIROMETER, DIAGNOSTIC FDA UDI
Model / Reference
Spiro Handle FDA UDI
Description
SPIROMETER, DIAGNOSTIC FDA UDI

Identifiers

Primary DI / UDI-DI
08809276943729 FDA UDI
510(k) Number
K130322 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

No

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
MRI Safety
MR Unsafe FDA UDI

Category: Diagnostic spirometer, professional

Spiro Handle by Bionet Company, Ltd. — 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
Bionet Company, Ltd.

Sources (1)

  • FDA UDI a0732f86-9aaa-46fc-a293-ced6827a76f4 34 fields · synced May 30, 2026