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AincA®

FDA UDI

Class II (US FDA UDI)

by Anesthesia Associates, Inc.

Identity

Trade Name
AincA® FDA UDI
Generic Name
Monitoring spirometer, mechanical FDA UDI
Device Name
Respirometer, Digital, Wright, Control Unit Only, Mates w/ 00-299, Part of 00-295 FDA UDI
Model / Reference
00-294 FDA UDI
Description
Respirometer, Digital, Wright, Control Unit Only, Mates w/ 00-299, Part of 00-295 FDA UDI

Identifiers

Catalog Number
00-294 FDA UDI
Primary DI / UDI-DI
B005002940 FDA UDI
510(k) Number
K903674 FDA UDI
FDA Product Code
BZK FDA UDI
GMDN Term
Monitoring spirometer, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1850 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: Monitoring spirometer, mechanical

AincA® by Anesthesia Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Monitoring spirometer, mechanical.

Cleared under the same submission

K903674 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anesthesia Associates, Inc.

Sources (1)

  • FDA UDI abcf95c9-3c46-442d-bf41-72fbc9da1f0e 36 fields · synced Jun 8, 2026