Shur-Clens

GUDID 00860006476038

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

Asept Pak, Inc.

Pressure-regulated wound irrigation solution applicator, manual

• Primary Device ID: 00860006476038
• NIH Device Record Key: af152412-ee63-4920-9b2d-96c080891c05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shur-Clens
• Version Model Number: 980093
• Company DUNS: 005245137
• Company Name: Asept Pak, Inc.
• Device Count: 24
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006476038 [Unit of Use]
GS1	10860006476035 [Primary]

FDA Product Code

• FQH: Lavage, Jet

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23

On-Brand Devices [Shur-Clens]

• 00860006476038: Case of 24 Containers of Sterile Sodium Chloride 0.9%, USP in 120 mL BFS Container.
• 20850073677005: Inner Carton containing 20 containers of 20 mL each of Hypochlorous Acid Solution