Indeflator

Basic Information

• Brand Name: Indeflator
• Primary DI: 08717648015267
• Version / Model: 1000185-115
• Catalog Number: 1000185-115
• Company Name: ABBOTT VASCULAR INC.
• Labeler DUNS: 964569052
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-05
• Public Version: 5
• Public Version Date: 2024-01-29
• Public Version Status: Update
• Public Device Record Key: 13c2f766-dc8d-4812-8ceb-d3c3ec8c1d87
• Distribution End Date: 2025-08-31

Device Description

PLUS 30 PRIORITY PACK Accessory Kit INDEFLATOR PLUS 30 Inflation Device 30 atm 10 cc / Rotating Hemostatic Valve .115 " / Guide Wire Introducer / Torque Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAV	Syringe, balloon inflation	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17541	Catheter/overtube balloon inflator, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717648015267	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, dark, cool place.