FDA.reportPublic FDA data

GM-30 Inflation Device

Primary DI
04543660022648
Brand
GM-30 Inflation Device
Company
Nipro Vascular Innovations Americas, Inc.
Model
GM-30N
Catalog number
GM-30N
Device description
30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
Published
2021-03-05
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
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
04543660022648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04543660022648045436600226484543660022648

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Pressure30Atmosphere
Total Volume25Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-596-3104customerservice@infraredx.com
800-596-3104customerservicenvia@nipromed.com

Regulatory Flags#

DUNS number
124065421
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
00857595006234Dualpro™ IVUS+NIRS Imaging Catheter Kit TVC-C195-42 TVC-C195-42 2018-07-11
00857595006494Dualpro™ IVUS+NIRS Imaging Catheter KitTVC-C195-42TVC-C195-422024-11-25
00857595006166Makoto Integrated Intravascular Imaging System™TVC-MC10iTVC-MC10i2022-11-11
00857595006180Infraredx Clarispro™ HD-IVUS Imaging Catheter KitTVC-E195-42 TVC-E195-42 2022-11-11
04543660023485GM-30 Accessory KitGLGMN-YOK0E2022-02-03
04543660023492GM-30 Accessory KitGLGMF-YOK0E2022-02-03
04543660023508GM-30 Accessory KitGLGMN-YOK0A2022-02-03
04543660023515GM-30 Accessory KitGLGMF-YOK0A2022-02-03
04543660022655GM-30 Inflation Device GM-30NFGM-30NF2021-03-05
04543660022662GM-30 Inflation Device GM-30NLGM-30NL2021-03-05
04543660022334OKAY® II Y-Connector SetYOK0A2019-10-28
04543660022341OKAY® II Y-ConnectorYOK0B2019-10-28
04543660022358OKAY® II Y-Connector Set with Extension TubeYOK0E2019-10-28
00857595006005TVC Controller Sterile BarrierTVC-MC8-B1TVC-MC8-B12016-08-22
00857595006203TVC Insight™ TVC-C195-20TVC-C195-202016-09-15
00857595006210TVC Insight™ TVC-C195-22TVC-C195-222016-09-15
00857595006227TVC Insight XB™TVC-C195-32TVC-C195-322016-09-15
00857595006401TVC Imaging System™TVC-MC8TVC-MC8 2016-09-15
00857595006418TVC Imaging System™TVC-MC8TVC-MC82016-09-15
00857595006425TVC Imaging System™TVC-MC9TVC-MC92018-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30197344203479NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
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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
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10859500005162StopLockFEMASYS INC.PTM2025-05-02
00859500005165StopLockFEMASYS INC.PTM2025-05-02
30859500005166StopLockFEMASYS INC.PTM2025-05-02
00884450860113basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
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00884450860106basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
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