AccessGUDID - DEVICE: Pharmaceutical Innovations (00300362101255)

GUDID

Device Identifier (DI) Information

Brand Name: Pharmaceutical Innovations
Version or Model: PI SPRAY Ultrasound Cleaning Solution
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36-2101-25
Company Name: PHARMACEUTICAL INNOVATIONS INC

Primary DI Number: 00300362101255
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067486548 *Terms of Use

Device Description: PI SPRAY Ultrasound Cleaning Solution: 250 ml Spray 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:	Yes
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?
47631	Medical device disinfection agent	A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: d2e0824b-6568-4379-9c74-378eab483ee5
Public Version Date: April 04, 2023
Public Version Number: 6
DI Record Publish Date: September 20, 2016