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Blairex Sterile Saline Solution

by Blairex Laboratories, Inc.

PMA P850045

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P850045↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP850045 Date29 Jun 1988ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Accessories, soft lens products
PMA Number
FDA Product Code
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S010 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Blairex Sterile Saline Solution is classified as an Accessory, Soft Lens Product under FDA nomenclature. It is a sterile, isotonic sodium chloride solution (0.9%) designed for ophthalmic use, specifically intended for cleaning, rinsing, or storing soft contact lenses.

Supplied in single-use containers, this solution is regulated under FDA PMA P850045 and falls under Device Class II (LPN product code). It is intended for sterile applications in ophthalmic settings and must be stored according to manufacturer guidelines to maintain integrity. No MRI safety or reusable specifications are noted in the regulatory data.

Other devices from Blairex Laboratories, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of the Blairex Sterile Saline Solution in clinical settings?

    The Blairex Sterile Saline Solution is specifically designed for ophthalmic use, intended for cleaning, rinsing, or storing soft contact lenses. Its sterile, isotonic formulation ensures compatibility with lens materials while maintaining hygiene standards for eyewear care.

  • How is the Blairex Sterile Saline Solution packaged and intended for use?

    The solution is supplied in single-use containers, which ensures sterility and reduces contamination risk. This packaging design aligns with sterile ophthalmic applications, where reusing containers could compromise cleanliness and safety.

  • Is the Blairex Sterile Saline Solution reusable, or is it meant for single-use only?

    The device is explicitly supplied in single-use containers, making it unsuitable for reuse. This design choice is critical for maintaining sterility and preventing cross-contamination in ophthalmic procedures.

  • What storage conditions should be followed to maintain the integrity of the Blairex Sterile Saline Solution?

    While specific storage instructions aren’t detailed in the regulatory data, the solution’s sterile nature requires adherence to manufacturer guidelines to preserve its isotonic properties and prevent contamination. Typically, this involves storing in a cool, dry place away from direct sunlight until use.

  • What regulatory pathway was followed for the approval of the Blairex Sterile Saline Solution?

    The solution was approved through the FDA’s Premarket Approval (PMA) process under PMA number P850045, classified as a Class II device under the product code LPN (Accessories, Soft Lens Products). This pathway is used for higher-risk devices requiring substantial evidence of safety and effectiveness.