AccessGUDID - DEVICE: Pure&Clean (00852421007430)

GUDID

Device Identifier (DI) Information

Brand Name: Pure&Clean
Version or Model: 22.08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4LP2
Company Name: Pure & Clean, LLC

Primary DI Number: 00852421007430
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045315650 *Terms of Use

Device Description: Pure&Clean Vision Source Lip Prep liquid spray, 2 oz bottle

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):	Yes
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?
58837	Eyelid solution	A fluid material intended to be applied to the eyelids for various therapeutic ocular applications that typically include provision of supplemental lipids on the eyelid margin to stabilize the natural tear film lipid layer in the treatment of tear film deficiencies (e.g., dry eye syndrome), or to clean the eyelid or eyelid margin in the treatment of blepharitis and/or meibomian gland dysfunction. It is typically a liposomal (e.g., phospholipid) suspension or a saline solution, and is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: more than 32 Degrees Fahrenheit
Storage Environment Temperature: more than 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Fluid Ounce

Device Record Status

Public Device Record Key: 70d0a419-32b3-4bbe-9dc8-15d1e8ba3ffc
Public Version Date: August 04, 2023
Public Version Number: 1
DI Record Publish Date: July 27, 2023

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 417-243-0000
Email: info@pncvision.com

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