GENOSS Inflator B40

GUDID 08809552962918

GENOSS CO., Ltd.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

Primary Device ID	08809552962918
NIH Device Record Key	e8a434ee-89ea-4cc9-a68e-a0f7c09efaee
Commercial Distribution Status	In Commercial Distribution
Brand Name	GENOSS Inflator B40
Version Model Number	GBI-B40
Company DUNS	690083006
Company Name	GENOSS CO., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809552962918 [Primary]

FDA Product Code

PTM	Syringe, Balloon Inflation, Exempt

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-06-26
Device Publish Date	2024-06-18

On-Brand Devices [GENOSS Inflator B40 ]

08809552962925	GBI-B40
08809552962918	GBI-B40
08800026512752	GBI-B40S
08800026507635	GBI-B40VS
08800026507611	GBI-B40V