FDA.reportPublic FDA data

QL Disposable Inflation Device

Primary DI
00856877002094
Brand
QL Disposable Inflation Device
Company
ATRION MEDICAL PRODUCTS, INC.
Model
QL®1015
Catalog number
96241
Device description
Inflation Device: 10mL, 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
HNWDilator, Lachrymal
KOEDilator, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856877002094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856877002094008568770020948568770020940856877002094

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
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.KOE2026-05-20
06976358503538SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503545SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503552SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503569SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503576SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503583SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00853095008341Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008358Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008365Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00190776400873MillenniumAvalign Technologies, Inc.HNW2025-06-05
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27