RGF-BioControls

GUDID 00811095020145

Isolation Room HEPA Filter Module with UV Lamps

RGF ENVIRONMENTAL GROUP, INC.

High-efficiency filter air cleaner, stationary

• Primary Device ID: 00811095020145
• NIH Device Record Key: 896c6a84-606a-4217-9a5f-de7a4218cdb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RGF-BioControls
• Version Model Number: EXC7-UV
• Company DUNS: 804797439
• Company Name: RGF ENVIRONMENTAL GROUP, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00811095020145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972064

FDA Product Code

• FRA: Purifier, Air, Ultraviolet, Medical

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: 2020-03-17
• Device Publish Date: 2020-03-09

On-Brand Devices [RGF-BioControls]

• 00811095020183: WallMAP PC Portable Unit 220V
• 00811095020176: WallMAP PC Portable Unit 110V
• 00811095020169: Microcon WallMAP Unit 220V
• 00811095020152: Microcon WallMAP Unit 110V
• 00811095020145: Isolation Room HEPA Filter Module with UV Lamps
• 00811095020138: Isolation Room HEPA Filter Module
• 00811095020121: Microcon MAP800 Air Purification Unit with UV Lamps for IsoPort - 220V
• 00811095020114: Microcon MAP800 Air Purification Unit with UV Lamps for IsoPort - 110V
• 00811095020107: Microcon MAP800 Air Purification Unit with UV Lamps - 220V
• 00811095020091: Microcon MAP800 Air Purification Unit with UV Lamps - 110V
• 00811095020084: Microcon MAP800 Air Purification Unit - 220V
• 00811095020077: Microcon MAP800 Air Purification Unit - 110V
• 00811095020060: Microcon MAP400 Air Purification Unit with UV Lamps for IsoPort - 220V
• 00811095020053: Microcon MAP400 Air Purification Unit with UV Lamps for IsoPort - 110V
• 00811095020046: Microcon MAP400 Air Purification Unit with UV Lamps - 220V
• 00811095020039: Microcon MAP400 Air Purification Unit with UV Lamps - 110V
• 00811095020022: Microcon MAP400 Air Purification Unit - 220V
• 00811095020015: Microcon MAP400 Air Purification Unit - 110V