FDA.reportPublic FDA data

basixCOMPAK™

Primary DI
10884450860110
Brand
basixCOMPAK™
Company
Merit Medical Systems, Inc.
Model
T
Catalog number
IN4802
Published
2025-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PTMSyringe, Balloon Inflation, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTMSyringe, Balloon Inflation, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450860110PackageGS110In Commercial Distribution
00884450860113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445086011010884450860110
00884450860113008844508601138844508601130884450860113

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

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06
00884450436745Merit Medical®Initial ReleaseK09-13832A2026-06-06
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941466829177Balloon Inflation DeviceBrosMed Medical Co.,Ltd.PTM2026-05-13
00884450544648basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
00884450638514basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
10197344203475NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
30197344203479NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
00884450440612basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
20884450440616basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
10889942546350NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
40889942546351NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
06936841212620Balloon Inflation DeviceTianck Medical Co., Ltd.PTM2025-11-12
06936841236329Balloon Inflation DeviceTianck Medical Co., Ltd.PTM2025-11-12
00884450098684basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450220092basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450098288basixTOUCH™Merit Medical Systems, Inc.PTM2025-10-07
00724995244538LumiflexUS EndoscopyPTM2025-08-19
10724995244535LumiflexUS EndoscopyPTM2025-08-19
00884450860373BIG60™Merit Medical Systems, Inc.PTM2025-05-31
10884450860370BIG60™Merit Medical Systems, Inc.PTM2025-05-31
20859500005169StopLockFEMASYS INC.PTM2025-05-02
10859500005162StopLockFEMASYS INC.PTM2025-05-02
00859500005165StopLockFEMASYS INC.PTM2025-05-02
30859500005166StopLockFEMASYS INC.PTM2025-05-02
00884450860113basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
00884450860106basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
10884450860103basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
00884450860953basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
10884450860950basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
00884450621370basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
00884450621394basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
20884450621374basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15