AccessGUDID - DEVICE: Shur-Clens (10860006476035)

GUDID

Device Identifier (DI) Information

Brand Name: Shur-Clens
Version or Model: 980093
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Asept Pak, Inc.

Primary DI Number: 10860006476035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 005245137 *Terms of Use

Device Description: Case of 24 Containers of Sterile Sodium Chloride 0.9%, USP in 120 mL BFS Container.

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?
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
FQH	Lavage, Jet

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: 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: af152412-ee63-4920-9b2d-96c080891c05
Public Version Date: May 01, 2025
Public Version Number: 1
DI Record Publish Date: April 23, 2025