FDA.reportPublic FDA data

NAMIC

Primary DI
10197344203475
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ40INFLT
Catalog number
DYNJ40INFLT
Device description
INFLATION,DEVICE,30ML,40ATM
Published
2026-03-16
Public version status
New
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
20197344203472PackageGS15In Commercial Distribution
30197344203479PackageGS120In Commercial Distribution
10197344203475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734420347220197344203472
3019734420347930197344203479
1019734420347510197344203475

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24
30193489017759MEDLINE6651CBL22X26651CBL22X22026-07-24
30193489017766MEDLINE6651CBL22X36651CBL22X32026-07-24
30193489017773MEDLINE6651CBL22X46651CBL22X42026-07-24
30193489017780MEDLINE6651CBL34X36651CBL34X32026-07-24
30193489017797MEDLINE6651CBL34X46651CBL34X42026-07-24
30193489104893MEDLINEMDT011201XLMDT011201XL2026-07-24
40193489107969MEDLINEMDTISO3AHCAR3MDTISO3AHCAR32026-07-24
40193489120241MEDLINEMDTISO3AHGMDTISO3AHG2026-07-24
40193489120258MEDLINEMDTISO3AHG3XLMDTISO3AHG3XL2026-07-24
50080196247576MEDLINEMDT011205MDT0112052026-07-24
50193489109885MEDLINEMDTISO3AHY3XLMDTISO3AHY3XL2026-07-24
50193489109892MEDLINEMDTISO3AHYCARMDTISO3AHYCAR2026-07-24
10193489987522MEDLINEURO175814TURO175814T2022-05-22
10193489987546MEDLINEURO175818TURO175818T2022-05-22
10193489988505MEDLINEURO175816TURO175816T2022-05-22
00080196311661MEDLINENON241278NON2412782026-07-23

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
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