QL Disposable Inflation Device 96520

GUDID 00856877002728

Inflation Device: 40mL, 15atm

ATRION MEDICAL PRODUCTS, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00856877002728
• NIH Device Record Key: 859fc601-1561-482c-9f40-8eca450cdc96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QL Disposable Inflation Device
• Version Model Number: QL® 4015
• Catalog Number: 96520
• Company DUNS: 047571476
• Company Name: ATRION MEDICAL PRODUCTS, INC.
• Device Count: 1
• 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: +1(800)343-9334
• Email: info@atrionmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856877002728 [Primary]

FDA Product Code

• KOE: Dilator, Urethral

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: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [QL Disposable Inflation Device]

• 00856877002650: Inflation Device Atrion Part Number 96515: 20mL, 30atm
• 00856877002728: Inflation Device: 40mL, 15atm