FDA.reportPublic FDA data

angiodynamics NAMIC Disposable Inflation Device

Primary DI
H965459830
Brand
angiodynamics NAMIC Disposable Inflation Device
Company
ATRION MEDICAL PRODUCTS, INC.
Model
QL2030PR
Catalog number
H965459830
Device description
Inflation Device Atrion Part Number 96468: 20mL, 30atm
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOEDilator, Urethral
MAVSyringe, Balloon Inflation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2
MAVSyringe, Balloon InflationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965459831PackageHIBCC10In Commercial Distribution
H965459830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)343-9334info@atrionmedical.com

Regulatory Flags#

DUNS number
047571476
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856877002780Everis, Inflation DeviceQL6015EID-60-152026-05-20
00856877002742QL Locking Syringe DeviceQL38X965272025-05-16
00856877002759QL Disposable Inflation DeviceQL® 2530965292025-05-16
00856877002766Atrion QL4515 Inflation DeviceQL4515965302025-05-16
00856877002773Atrion QL4515 Inflation DeviceQL4515965312025-05-16
00856877002704Atrion QL4515 Inflation DeviceQL4515965182024-08-06
00856877002735QL Inflation DeviceQL® 6020965222024-08-06
00856877002728QL Disposable Inflation DeviceQL® 4015965202022-11-07
00856877002711PAVmed™ Inflation DeviceQL4015965192021-11-29
00856877002667QL Locking Syringe DeviceQL38X965032021-06-23
00856877002650QL Disposable Inflation DeviceQL2030PR965152021-01-27
00856877002087QL Disposable Inflation DeviceQL®1015AQL 10152016-09-19
00856877002094QL Disposable Inflation DeviceQL®1015962412016-09-19
00856877002100QL Disposable Inflation DeviceQL®1030962522016-09-19
00856877002124QL Disposable Inflation DeviceQL®2015962862016-09-19
00856877002261QL Disposable Inflation DeviceQL® 2030963942016-09-20
00856877002278QL Disposable Inflation DeviceQL®1430964052016-09-20
00856877002315panmed u.s. PAN MEDICAL Disposable Inflation DeviceQL1455964962017-10-06
00856877002346AERIS Inflation DeviceQL2530964992018-07-09
00856877002353QL Disposable Inflation DeviceQL® 2030964242016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2026-05-20
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2026-05-20
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00884450830697Monarch®Merit Medical Systems, Inc.MAV2024-12-20
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
06936881102530Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136382Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136399Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136405Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136412Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136429Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136436Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136443Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136450Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136467Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136474Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881102516Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
06936881102523Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10