Shur-Clens

GUDID 20850073677005

Inner Carton containing 20 containers of 20 mL each of Hypochlorous Acid Solution

Asept Pak, Inc.

Pressure-regulated wound irrigation solution applicator, manual

• Primary Device ID: 20850073677005
• NIH Device Record Key: e363f30c-c29a-46d5-b691-3e0df5c893ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shur-Clens
• Version Model Number: 980099
• Company DUNS: 005245137
• Company Name: Asept Pak, Inc.
• Device Count: 20
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com
• Phone: (518) 651-2026
• Email: ghanley@aseptpak.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850073677001 [Unit of Use]
GS1	10850073677008 [Primary]
GS1	20850073677005 [Package]; Contains: 10850073677008; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• FQH: Lavage, Jet

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

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