NOVAPLUS 47597

GUDID 30680651475979

Novaplus ASTM Fluid-Rated Fog-Free Procedure Mask, Blue, WrapAround Visor

O&M HALYARD, INC.

Surgical/medical face mask, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 30680651475979
• NIH Device Record Key: 5b4d9f30-d7d2-4d06-a3ac-1a6cd7cb16f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVAPLUS
• Version Model Number: 47597
• Catalog Number: 47597
• Company DUNS: 081057389
• Company Name: O&M HALYARD, INC.
• Device Count: 25
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20680651475972 [Primary]
GS1	30680651475979 [Package]; Contains: 20680651475972; Package: CS [4 Units]; In Commercial Distribution
GS1	90680651475971 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823078

FDA Product Code

• FXX: Mask, 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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-05-16

On-Brand Devices [NOVAPLUS]

• 30680651475979: Novaplus ASTM Fluid-Rated Fog-Free Procedure Mask, Blue, WrapAround Visor
• 30680651475962: Novaplus ASTM Fluid-Rated Procedure Mask, White
• 30680651475955: Novaplus ASTM Fluid-Rated Procedure Mask, Blue
• 30680651475948: Novaplus ASTM Fluid-Rated Procedure Mask, Yellow
• 30680651475931: Novaplus Expanded Chamber Surgical Mask, Blue
• 30680651475924: Novaplus ASTM Fluid-Rated Surgical Mask, Horizontal Ties, Blue
• 30680651475917: Novaplus ASTM Fluid-Rated Surigcal Mask, White
• 30680651475900: Novaplus ASTM Fluid-Rated Surigcal Mask, Blue
• 30680651475894: Novaplus ASTM Fluid-Rated Procedure Mask, Blue
• 30680651475887: Novaplus ASTM Fluid-Rated Fog-Free Procedre Mask, Aqua
• 30680651475870: Novaplus ASTM Fluid-Rated Fog-Free Surgical Mask, Aqua