FDA.reportPublic FDA data

Balloon Inflation Device

Primary DI
06941466829177
Brand
Balloon Inflation Device
Company
BrosMed Medical Co.,Ltd.
Model
rev 01
Catalog number
BM-BID-II30
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06941466829177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941466829177069414668291776941466829177

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.

Regulatory Flags#

DUNS number
421318800
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942265520807Parafleet SC 035 PTA Balloon Dilatation Catheterrev 02F35-060200-2002025-05-13
06942265502018Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-035300-0902025-05-09
06942265502025Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040015-0902025-05-09
06942265502032Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040020-0902025-05-09
06942265502049Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040025-0902025-05-09
06942265502056Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040030-0902025-05-09
06942265502063Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040040-0902025-05-09
06942265502070Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040060-0902025-05-09
06942265502087Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040080-0902025-05-09
06942265502094Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040100-0902025-05-09
06942265502100Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040120-0902025-05-09
06942265502117Parafleet SC 014PTA Balloon Dilatation Catheterrev 02F14-040150-0902025-05-09
06942265502124Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040200-0902025-05-09
06942265502131Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040220-0902025-05-09
06942265502148Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040250-0902025-05-09
06942265502155F14-040300-090rev 01F14-040300-0902025-05-09
06942265502162Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045015-0902025-05-09
06942265502179Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045020-0902025-05-09
06942265502186Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045025-0902025-05-09
06942265502193Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045030-0902025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884450860110basixCOMPAK™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