Hope PG-MHL1

GUDID D066PGMHL11

Ear-loop Mask: HOPE - Blue (Level 1)

Proguard Health, Inc

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

• Primary Device ID: D066PGMHL11
• NIH Device Record Key: 8d5ffdc8-d5f4-41c2-9a8e-798b762c1553
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hope
• Version Model Number: PG-MHL1
• Catalog Number: PG-MHL1
• Company DUNS: 129529337
• Company Name: Proguard Health, Inc
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
HIBCC	D066PGMHL10 [Unit of Use]
HIBCC	D066PGMHL11 [Primary]
HIBCC	D066PGMHL12 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023755

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-12
• Device Publish Date: 2021-07-02

Devices Manufactured by Proguard Health, Inc

• D066PG10162 - PlastCare: 2021-07-12 Sterilization Pouches (10" x 16")
• D066PG12192 - PlastCare: 2021-07-12 Sterilization Pouches (12" x 19")
• D066PG22042 - PlastCare: 2021-07-12 Gauze Non Woven Sponges 2 x 2 Inch
• D066PG23372 - PlastCare: 2021-07-12 Sterilization Pouches (2.25" x 3.75")
• D066PG23502 - PlastCare: 2021-07-12 Sterilization Pouches (2.25" x 5")
• D066PG23902 - PlastCare: 2021-07-12 Sterilization Pouches (2.25" x 9")
• D066PG27102 - PlastCare: 2021-07-12 Sterilization Pouches (2.75" x 10")
• D066PG30342 - PlastCare: 2021-07-12 Cotton Rolls 1 1/2" x 3/8"