AccessGUDID - DEVICE: PERFLUORON (00380659001635)

GUDID

Device Identifier (DI) Information

Brand Name: PERFLUORON
Version or Model: 0090010015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8065900163
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380659001635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: PFNO KIT 5ML<USA Kit Contents: One 5 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36108	Aqueous/vitreous humour replacement medium kit	A collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWL	Fluid, Intraocular

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
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: a4e4c8ad-c906-4a00-815a-3369e876cdcf
Public Version Date: January 24, 2022
Public Version Number: 4
DI Record Publish Date: March 06, 2015