FDA.reportPublic FDA data

Accessory Kit

Primary DI
00850048825055
Brand
Accessory Kit
Company
Noah Medical Corporation
Model
10000799
Device description
Galaxy system accessory kit
Published
2024-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223144000Galaxy SystemNoah Medical Corp.2023-03-01EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048825055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048825055008500488250558500488250550850048825055

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, reusableAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
117566482
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048825062Galaxy II system Wired Controller100001112024-12-15
00850048825093Galaxy System - HKGALRB-HK-0012026-04-21
00000850048825Galaxy System - HKGALRB-HK-0012026-04-21
00850048825086Galaxy System (Cart) - RefurbishedGALRB-0012025-10-25
00850048825048Galaxy SystemGAL-0012025-02-28
00850048825000Bronchoscope100007692024-12-11
00850048825017Bronchoscope connector100003392024-12-11
00850048825031Bronchoscope guide100003072024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826920950PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
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04580826928284PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04547410524642FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
04547410524680FUJIFILMFUJIFILM CORPORATIONEOQ2026-07-30
06972084140634WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28