N95 Respirator

GUDID 00616784229539

DYNAREX CORPORATION

Surgical/medical respirator, single-use Surgical/medical respirator, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 00616784229539
• NIH Device Record Key: b96b0527-a761-46c6-9156-104431995a86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N95 Respirator
• Version Model Number: 2295
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784229515 [Unit of Use]
GS1	00616784229522 [Primary]
GS1	00616784229539 [Package]; Contains: 00616784229522; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• MSH: Respirator,Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [N95 Respirator]

• 00616784229638: 2296
• 00616784229539: 2295