AccessGUDID - DEVICE: The Pyure Company (00819355020218)

GUDID

Device Identifier (DI) Information

Brand Name: The Pyure Company
Version or Model: MDU/RX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00819355020218
Company Name: The Pyure Company Inc

Primary DI Number: 00819355020218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117749345 *Terms of Use

Device Description: Medical Ultraviolet Air Cleaner

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65418	Ultraviolet-activated air cleaner	An air purification device intended to destroy airborne pathogens and pollutants (e.g., volatile organic compounds) in the ambient air of an enclosed room/area using ultraviolet (UV) radiation light applied to the air before being ventilated/recirculated to the room. It consists of an electrically-powered unit with an enclosed optic chamber in which air is exposed to UV energy whereby disinfection is achieved through hydroxyl radicals (produced by the reaction between UV energy and water vapour), or by a UV-activated photocatalyst (e.g., titanium dioxide). It may be a floor-standing device or a unit integrated into the facility ventilation system, and may include air filters (e.g., HEPA).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRA	Purifier, Air, Ultraviolet, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133800	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f77a3f29-903a-41a7-8d48-2b9e79cb106e
Public Version Date: January 10, 2023
Public Version Number: 2
DI Record Publish Date: April 12, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 561-735-3701
Email: acastillo@pyureco.com

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