SuperFlow Tubing Set

GUDID 10850082007049

Irrigation / Infiltration Tubing Set, Large

ARMM INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 10850082007049
• NIH Device Record Key: 5499331c-16c7-48a4-ad1b-03db106ca8ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperFlow Tubing Set
• Version Model Number: 21515
• Company DUNS: 797391778
• Company Name: ARMM INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• 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: false

Customer Support Contacts

• Phone: 7148488190
• Email: info@armminc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850082007042 [Unit of Use]
GS1	10850082007049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981286

FDA Product Code

• KDH: Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-08-29

On-Brand Devices [SuperFlow Tubing Set]

• 10850082007063: Suction / Irrigation Wye Tubing Set
• 10850082007056: Irrigation / Infiltration Tubing Set, 10 per Box
• 10850082007049: Irrigation / Infiltration Tubing Set, Large
• 10850082007032: Irrigation / Infiltration Tubing Set, Small
• 10850082007025: Suction / Irrigation Wye Tubing Set with Valves
• 10850082007018: Irrigation Tubing with Spike