FDA.reportPublic FDA data

basixCOMPAK™

Primary DI
20884450299368
Brand
basixCOMPAK™
Company
Merit Medical Systems, Inc.
Model
00884450299364
Catalog number
IN4330/F
Published
2022-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
10884450299361PackageGS15In Commercial Distribution
20884450299368PackageGS14In Commercial Distribution
00884450299364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029936110884450299361
2088445029936820884450299368
00884450299364008844502993648844502993640884450299364

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
true
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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450021344DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
10884450021269DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
10884450021252DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00856877002742QL Locking Syringe DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
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
20197344104939NAMICMEDLINE INDUSTRIES, INC.MAV2024-09-09
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
20197344013781NAMICMEDLINE INDUSTRIES, INC.MAV2024-06-14
06947358563402Sunmed Inflation devicesSunny Medical Device (Shenzhen) Co., Ltd.MAV2023-09-25
26950900920015INT,Force Inflation DeviceShanghai Kindly Medical Instruments Co., Ltd.MAV2023-08-15
26950900920039INT,Force Inflation DeviceShanghai Kindly Medical Instruments Co., Ltd.MAV2023-08-15
16943718223242DemaxBeijing Demax Medical Technology Co., Ltd.MAV2022-09-12
16943718223259DemaxBeijing Demax Medical Technology Co., Ltd.MAV2022-09-12
16943718223266DemaxBeijing Demax Medical Technology Co., Ltd.MAV2022-09-12
16943718223273DemaxBeijing Demax Medical Technology Co., Ltd.MAV2022-09-12
16943718223280DemaxBeijing Demax Medical Technology Co., Ltd.MAV2022-09-12
16943718223297DemaxBeijing Demax Medical Technology Co., Ltd.MAV2022-09-12
20884450544666basixCOMPAK™Merit Medical Systems, Inc.MAV2022-04-27
20884450535138basixCOMPAK™Merit Medical Systems, Inc.MAV2021-12-13
10884450544591basixCOMPAK™Merit Medical Systems, Inc.MAV2021-11-26
20884450544536basixCOMPAK™Merit Medical Systems, Inc.MAV2021-10-28
10884450544676basixCOMPAK™Merit Medical Systems, Inc.MAV2021-10-28
20884450544628basixCOMPAK™Merit Medical Systems, Inc.MAV2021-09-27
20884450535251basixCOMPAK™Merit Medical Systems, Inc.MAV2021-09-10
20884450544659basixCOMPAK™Merit Medical Systems, Inc.MAV2021-09-07