AccessGUDID - DEVICE: PuriLens Plus Preservative Free Saline (00830002000018)

GUDID

Device Identifier (DI) Information

Brand Name: PuriLens Plus Preservative Free Saline
Version or Model: 4 oz. (120 mL) Bottle
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFESTYLE CO INC, THE

Primary DI Number: 00830002000018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 946065000 *Terms of Use

Device Description: PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with boric acid and sodium borate. PuriLens Plus Preservative-Free Saline is sterilized and packaged using aseptic processing (blow- fill-seal).

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?
60838	Contact lens rinsing solution	A sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRC	Products, Contact Lens Care, Rigid Gas Permeable
LPN	Accessories, Soft Lens Products

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: Yes
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: 1704f026-b30f-49cf-b064-642884fcecc4
Public Version Date: October 24, 2024
Public Version Number: 2
DI Record Publish Date: September 24, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00830002000087	3	00830002000018	In Commercial Distribution	3-pack carton
00830002000025	12	00830002000018	In Commercial Distribution	12-pack carton
00830002000124	6	00830002000018	In Commercial Distribution	6-pack carton