Device
Inflation Device Atrion Part Number 96532: 60mL, 15atm
Manufacturer
ATRION MEDICAL PRODUCTS, INC.
Model: QL6015 Catalog: EID-60-15 DI: 00856877002780 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Description
Inflation Device Atrion Part Number 96532: 60mL, 15atm
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: b42bd563-d362-4045-ae8d-d10d1d57634c
Distribution Status: In Commercial Distribution
DUNS Number: 047571476
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00856877002780
Type: Primary
Issuing Agency: GS1
GMDN
Code: 17541
Name: Catheter/overtube balloon inflator, single-use
Definition:
A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
FDA Product Codes
KOE
Dilator, Urethral
MAV
Syringe, Balloon Inflation