FDA.reportPublic FDA data

PAVmed™ Inflation Device

Primary DI
00856877002711
Brand
PAVmed™ Inflation Device
Company
ATRION MEDICAL PRODUCTS, INC.
Model
QL4015
Catalog number
96519
Device description
Inflation Device Atrion Part Number 96519: 40mL, 15atm
Published
2021-11-29
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
PTMSyringe, Balloon Inflation, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2
PTMSyringe, Balloon Inflation, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856877002711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856877002711008568770027118568770027110856877002711

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
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
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
00884450544648basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
00884450638514basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
10197344203475NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
00884450440612basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
10889942546350NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
00884450098684basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450220092basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00884450098288basixTOUCH™Merit Medical Systems, Inc.PTM2025-10-07
00724995244538LumiflexUS EndoscopyPTM2025-08-19
00884450860373BIG60™Merit Medical Systems, Inc.PTM2025-05-31
20859500005169StopLockFEMASYS INC.PTM2025-05-02
00884450860113basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
00884450860106basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
00884450860953basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
00884450621370basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
00884450621394basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
10884450822514basixSKY™Merit Medical Systems, Inc.PTM2024-12-28
10197344104932NAMICMEDLINE INDUSTRIES, INC.PTM2024-09-09
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
10884450822521basixSKY™Merit Medical Systems, Inc.PTM2024-06-18
10197344013784NAMICMEDLINE INDUSTRIES, INC.PTM2024-06-14
10884450822507basixSKY™Merit Medical Systems, Inc.PTM2024-05-23
10884450812959basixSKY™Merit Medical Systems, Inc.PTM2024-05-18
00884450621349basixTOUCH™Merit Medical Systems, Inc.PTM2024-03-05
00884450413487BlueFIRE™Merit Medical Systems, Inc.PTM2024-01-05
00884450363607BlueFIRE™Merit Medical Systems, Inc.PTM2023-06-06