AccessGUDID - DEVICE: Irrisept Wound Solution Kit (10842351180010)

GUDID

Device Identifier (DI) Information

Brand Name: Irrisept Wound Solution Kit
Version or Model: ISEPT-WS-USA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IRRIMAX CORPORATION

Primary DI Number: 10842351180010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
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 with hanger and spikeable cap.

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:	Yes
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?
62394	Pressure-regulated wound irrigation solution applicator, manual	A hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug
FQH	LAVAGE, JET

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240552	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 8b821054-3f01-429a-9657-2dca013a0bf6
Public Version Date: July 09, 2024
Public Version Number: 1
DI Record Publish Date: July 01, 2024