FDA.reportPublic FDA data

Balloon Inflator

Primary DI
06923558506487
Brand
Balloon Inflator
Company
Jiangsu Changmei Medtech Co., Ltd.
Model
BI-20A-10
Device description
20 mL capacity, A type, with 10 mL syringe
Published
2025-10-21
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
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923558506487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923558506487069235585064876923558506487

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Contacts#

Phone, Email table
PhoneEmail
+008651988520118sales@czmed.com

Regulatory Flags#

DUNS number
560432633
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
06923558507569Kyphoplasty Tool KitKT-00-052025-10-23
06923558509693Kyphoplasty Tool KitKT-00-062025-10-23
06923558506968Kyphoplasty Balloon CatheterKB0120S12025-10-21
06923558507385Kyphoplasty Balloon CatheterKB0115S12025-10-21
06923558509709Kyphoplasty Balloon CatheterKB0210S12025-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
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08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
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08800038058293SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
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08800038058316SYNTH™ PLUS BILATERALIMEDICOM CO., LTD.HXG2024-03-25
08800038058323SYNTH™ PLUS BILATERALIMEDICOM CO., LTD.HXG2024-03-25
08800038058330SYNTH™ PLUS BILATERALIMEDICOM CO., LTD.HXG2024-03-25