Grafco

GUDID M3683813B2

Cone Face Mask

GF HEALTH PRODUCTS, INC.

Surgical/medical face mask, single-use

• Primary Device ID: M3683813B2
• NIH Device Record Key: b8300ec4-67f5-4f59-ab37-ea4730eff6d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grafco
• Version Model Number: 3813B
• Company DUNS: 132016168
• Company Name: GF HEALTH PRODUCTS, INC.
• Device Count: 100
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M3683813B0 [Unit of Use]
HIBCC	M3683813B1 [Primary]
HIBCC	M3683813B2 [Package]; Contains: M3683813B1; Package: [10 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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Grafco]

• M368UNNAC42: UNNA'S Boot Dressing with Calamine
• M368UNNAC32: UNNA'S Boot Dressing with Calamine
• M368UNNA42: UNNA'S Boot Dressing
• M368UNNA32: UNNA'S Boot Dressing
• M368GFDF52: Premium Dual Function Stimulator
• M3681565C42: Medicopaste Bandage with Calamine
• M3681565C32: Medicopaste Bandage with Calamine
• M368156542: Medicopaste Bandage
• M368156532: Medicopaste Bandage
• M368GFTX5EMS3: Digital EMS TENS Unit
• M368GFTX53: Digital TENS Unit
• M368GF3T3: TENS Unit, Analog
• M368GF33: TENS Unit, Analog
• M3684002GF2: Ultrasound Gel
• M3684001GF2: Ultrasound Gel
• M36838162: Face Mask w/ Earloops
• M36838142: Face Mask w/ Ties
• M3683813B2: Cone Face Mask
• M368450712: Electric Heating Pad - Moist Heat
• M36883761: Stainless Steel Sterilizer, Dry Heat
• M36883751: Stainless Steel Sterilizer, Dry Heat
• M368GFTT52: Tera TENS
• M368C1012: Disposable Instant Cold Pack
• M368C1002: Disposable Instant Cold Pack
• M36812752: Eye Protector
• M36812732: Flat Eye Protector
• M36892613: TENS Electrodes
• M36892603: TENS Electrodes
• M3683786KT0: BERMAN ORAL AIRWAY KIT
• M3683786B10: BERMAN ORAL AIRWAY (50MM) INFANT
• M3683786B00: BERMAN ORAL AIRWAY (40MM) NEONATAL
• M36837861250: BERMAN ORAL AIRWAY (100MM) LRG ADLT
• M36837861240: BERMAN ORAL AIRWAY (90MM) MED ADLT
• M36837861230: BERMAN ORAL AIRWAY (80MM) SML ADULT
• M36837861220: BERMAN ORAL AIRWAY (60MM) SML CHILD
• M36837861210: BERMAN ORAL AIRWAY (50MM) INFANT
• M36837861200: BERMAN ORAL AIRWAY (40MM) NEONATAL
• M3683786B20: BERMAN ORAL AIRWAY (60MM) SML CHLD
• M36838562: BIB PATIENT/GERIATRIC
• M36838552: APRON UTILITY 42"X36"
• M36838542: APRON UTILITY 36"X27"
• M36838532: APRON NECK-CLASP
• M36822031: UV Magnifier Lamp
• M36822001: UV Magnifier Lamp
• M3683953580: TUBING PENROSE DRAIN5/8" 25/BX
• M3683953340: TUBING PENROSE DRAIN 3/4"
• M3683953140: TUBING PENROSE DRAIN 1/4"
• M3683953120: TUBING PENROSE DRAIN 1/2
• M368395310: TUBING PENROSE DRAIN 1" 25/BX
• M36834130: FEEDING TUBE BRUSH 12/BX