FDA.reportPublic FDA data

basixCOMPAK™

Primary DI
10884450638313
Brand
basixCOMPAK™
Company
Merit Medical Systems, Inc.
Model
00884450638316
Catalog number
IN4230/K
Published
2022-06-04
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
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
10884450638313PackageGS110In Commercial Distribution
00884450638316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445063831310884450638313
00884450638316008844506383168844506383160884450638316

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
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
30197344203479NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
20884450440616basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
40889942546351NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
10724995244535LumiflexUS EndoscopyPTM2025-08-19
10884450860370BIG60™Merit Medical Systems, Inc.PTM2025-05-31
10859500005162StopLockFEMASYS INC.PTM2025-05-02
00859500005165StopLockFEMASYS INC.PTM2025-05-02
30859500005166StopLockFEMASYS INC.PTM2025-05-02
10884450860110basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
10884450860103basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
10884450860950basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
20884450621374basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
10884450621391basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
00884450822517basixSKY™Merit Medical Systems, Inc.PTM2024-12-28
20197344104939NAMICMEDLINE INDUSTRIES, INC.PTM2024-09-09
16970057578429Balloon InflatorsJiangsu Vedkang Medical Science and Technology Co.,Ltd.PTM2024-08-20
06971162817789Balloon inflation deviceTianck Medical Co., Ltd.PTM2024-08-02
08800026501558GENOSS Inflator B30GENOSS CO., Ltd.PTM2024-06-18
08800026501565GENOSS Inflator B30GENOSS CO., Ltd.PTM2024-06-18
08800026507598GENOSS Inflator B30GENOSS CO., Ltd.PTM2024-06-18
08800026507611GENOSS Inflator B40 GENOSS CO., Ltd.PTM2024-06-18
08800026507635GENOSS Inflator B40 GENOSS CO., Ltd.PTM2024-06-18
08800026512752GENOSS Inflator B40 GENOSS CO., Ltd.PTM2024-06-18
08800026530329GENOSS Inflator B30GENOSS CO., Ltd.PTM2024-06-18
08809324765433GENOSS Inflator B30GENOSS CO., Ltd.PTM2024-06-18
08809552962918GENOSS Inflator B40 GENOSS CO., Ltd.PTM2024-06-18
08809552962925GENOSS Inflator B40 GENOSS CO., Ltd.PTM2024-06-18
00884450822524basixSKY™Merit Medical Systems, Inc.PTM2024-06-18
20197344013781NAMICMEDLINE INDUSTRIES, INC.PTM2024-06-14
00884450822500basixSKY™Merit Medical Systems, Inc.PTM2024-05-23