AccessGUDID - DEVICE: Irrisept Antimicrobial Wound Lavage (10842351190002)

GUDID

Device Identifier (DI) Information

Brand Name: Irrisept Antimicrobial Wound Lavage
Version or Model: ISEPT-450-USA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9000
Company Name: IRRIMAX CORPORATION

Primary DI Number: 10842351190002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 142661078 *Terms of Use

Device Description: 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	LAVAGE, JET
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 450 Milliliter

Device Record Status

Public Device Record Key: 8c2b72f1-10e4-4771-b0af-e24df0f9d24f
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: May 01, 2018