PlastCare PG-MBK2

GUDID D066PGMBK22

Ear-Loop Mask Black (Level 2)

Proguard Health, Inc

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 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 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: D066PGMBK22
• NIH Device Record Key: 1c8a78db-bc5d-4505-ac81-12e95b89d906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlastCare
• Version Model Number: PG-MBK2
• Catalog Number: PG-MBK2
• 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	D066PGMBK20 [Unit of Use]
HIBCC	D066PGMBK21 [Primary]
HIBCC	D066PGMBK22 [Package]; Contains: D066PGMBK21; 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

On-Brand Devices [PlastCare]

• D066PGWHW2: Saliva Ejector White With White Tip
• D066PGSTRSS25102: Syringe Sleeves with Pre-Cut Opening (2-1/2" x 10")
• D066PGSTRS81832: X-Ray Sensor Sleeves (8" x 1-5/8")
• D066PGSTRS81252: X-Ray Sensor Sleeves (8" x 1-3/8")
• D066PGSTRS27242: Half Chair Sleeves (27-1/2" x 24")
• D066PGSTRS25102: Digital X-Ray Sensor Sleeves (2-1/2" x 10")
• D066PGSTRS15262: X-Ray Head Sleeves (15" x 26")
• D066PGSTRS11162: Tray Sleeves (11-5/8" x 16")
• D066PGSTRS105142: Tray Sleeves (10-1/2" x 14")
• D066PGSTRS10142: Headrest Covers Sleeves (10" x 14")
• D066PGSTRS10112: Headrest Covers Sleeves (10" x 11")
• D066PGSTA003B1: Surgical Aspirator Tips Small Vented 1/16" Diam (Blue)
• D066PGSTA002G1: Surgical Aspirator Tips Large Vented 1/4" Diam (Green)
• D066PGSTA001W1: Surgical Aspirator Tips Medium Vented 1/8" Diam (White)
• D066PGSIDEW2: Bite Registration Tray Sideless (White)
• D066PGS3CC30GKIT2: Irrigation Needle With Half Cutting Tips: 30Cc Syringe + 30G
• D066PGS3CC27GKIT2: Irrigation Needle With Half Cutting Tips: 3Cc Syringe + 27G
• D066PGS3CC25GKIT2: Irrigation Needle With Half Cutting Tips: 3Cc Syringe + 25G
• D066PGS12CC2: Irrigation Needle With Half Cutting Tips Utility Syringe 12 Cc
• D066PGQUADY2: Bite Registration Tray Quadrant (Yellow)
• D066PGPOSTG2: Bite Registration Tray Posterior Classic Short (Green )
• D066PGPOSTB0: Bite Registration Tray Posterior (Blue)
• D066PGPNK2: Saliva Ejector Pink With Pink Tip
• D066PGPCL2: Saliva Ejector Purple With Clear Tip
• D066PGNEEDLE30GXS42: Anesthetic Dental Needles 30G/X-Short, 0.3mm x 12 mm (Blue)
• D066PGNEEDLE30GS42: Anesthetic Dental Needles 30G/Short, 0.3mm x 21 mm (Blue)
• D066PGNEEDLE27GS40: Anesthetic Dental Needles 27G/SHORT, 0.4mm x 30mm (Yellow)
• D066PGNEEDLE27GL42: Anesthetic Dental Needles 27G/Long, 0.4mm x 30mm (Yellow)
• D066PGMBL32: Ear-Loop Mask Blue (Level 3)
• D066PGMBL22: Ear-Loop Mask Blue (Level 2)
• D066PGMBL12: Ear-Loop Mask Blue (Level 1)
• D066PGMBK32: Ear-Loop Mask Black (Level 3)
• D066PGMBK22: Ear-Loop Mask Black (Level 2)
• D066PGMBK12: Ear-Loop Mask Black (Level 1)
• D066PGMA11030: Micro Applicators Regular (Purple)
• D066PGMA11022: Micro Applicators Regular (Orange)
• D066PGMA11010: Micro Applicators Regular (Green)
• D066PGMA11002: Micro Applicators Regular (Blue)
• D066PGMA10022: Micro Applicators Fine (Yellow)
• D066PGMA10012: Micro Applicators Fine (Mauve)
• D066PGMA10002: Micro Applicators Superfine (White)
• D066PGHVE022: Vented Evacuation Tips Rainbow
• D066PGHVE012: Vented Evacuation Tips White
• D066PGG41002: Silicone Dispenser Gun 4:1 & 10:1
• D066PGG11002: Silicone Dispenser Gun 1:1 & 2:1
• D066PGFULLAP2: Bite Registration Tray Full Arch (Pink)
• D066PGFT272: Pre-bent Flow Dispensing Tips 27G (Gray)
• D066PGFT250: Pre-bent Flow Dispensing Tips 25G (Orange)
• D066PGFT230: Pre-bent Flow Dispensing Tips 23G (Blue)
• D066PGFT210: Pre-bent Flow Dispensing Tips 21G (Green)