Spirair

FDA Device Registration & Listing · Mountain View, CA, US · Registration 3043562110

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043562110
FEI Number
3043562110
Entity Name
Spirair
City/State/Country
Mountain View, CA, US
Establishment Address
2570 W El Camino Real Ste 310, Mountain View, CA 94040, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Spirair, Inc (Owner Number: 10090843)
Owner / Operator Contact Address
415 Grand Avenue, Suite 201, South San Francisco, CA 94080, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

TurbAlign

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2026-02-19
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2025-08-26

Official Correspondent

Tracey Henry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spirair, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3030653921 SPIRAIR, INC South San Francisco, CA, US

Similar Registrations

Registration Number Establishment Name Location
3007225047 HEMOSTASIS, LLC Saint Paul, MN, US
1450662 Isomedix Operations, Inc. Libertyville, IL, US
3012448339 STERI-TEK Fremont, CA, US
1058584 Sterigenics US LLC Charlotte, NC, US
1220477 ISOMEDIX OPERATIONS INC. Northborough, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043562110. Last updated year: 2026. Please use registration number 3043562110 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.