FDA.reportPublic FDA data

QL Disposable Inflation Device

Primary DI
00856877002124
Brand
QL Disposable Inflation Device
Company
ATRION MEDICAL PRODUCTS, INC.
Model
QL®2015
Catalog number
96286
Device description
Inflation Device: 20mL, 15atm
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
MAVSyringe, Balloon Inflation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAVSyringe, Balloon InflationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856877002124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856877002124008568770021248568770021240856877002124

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
H965459830angiodynamics NAMIC Disposable Inflation DeviceQL2030PRH9654598302016-09-19
00856877002087QL Disposable Inflation DeviceQL®1015AQL 10152016-09-19
00856877002094QL Disposable Inflation DeviceQL®1015962412016-09-19
00856877002100QL Disposable Inflation DeviceQL®1030962522016-09-19
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
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
10884450021344DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
10884450021269DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
10884450021252DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00856877002742QL Locking Syringe DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
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
06943718223344DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223351DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223368DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223375DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223382DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223337DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223341DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223358DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223365DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223372DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223389DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
20197344104939NAMICMEDLINE INDUSTRIES, INC.MAV2024-09-09
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
20197344013781NAMICMEDLINE INDUSTRIES, INC.MAV2024-06-14