FDA.reportPublic FDA data

DRY320

Primary DI
DRY320
Brand
DRY320
Company
Wassenburg Medical, Inc.
Model
DRY320
Device description
A device to store and dry endoscopes
Published
2023-10-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRJUnit, Drying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRJUnit, DryingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G434DRY320PackageHIBCC1Not in Commercial Distribution
DRY320PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope drying/storage cabinetAn electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37º Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.

Contacts#

Phone, Email table
PhoneEmail
12153641477m.infanti@wassenburgmedical.com

Regulatory Flags#

DUNS number
118762097
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010835265Wassenburg Transport Cart TC-6TC-62024-04-23
STORAGECABINET20000Storage Cabinet200002021-09-07
SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92016-09-25
G434SC200001Storage Cabinet20000E001882023-07-27
G434FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62023-08-11
G434FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82023-08-11
SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22016-09-25
FLUSHINGSINKMODELS6Scope Assist Flushing Sink (SAFS)S62017-05-16
FLUSHINGSINKMODELS8Scope Assist Flushing Sink (SAFS)S82017-05-16
00860010835241System 83 RevolveSystem 83 Revolve2025-02-24
00860010835203Storage Cabinet200002024-04-23
00860010835210Scope Assist Flushing Sink (SAFS)S62024-04-23
00860010835227Scope Assist Flushing Sink (SAFS)S82024-04-23
00860010835234DRY320DRY3202024-04-23
G434DRY320DRY320DRY3202023-10-31
G434SYSTEM83PLUS2SYSTEM 83 PLUSSYSTEM 83 PLUS 22023-08-15
G434SYSTEM83PLUS9SYSTEM 83 PLUSSYSTEM 83 PLUS 92023-08-11
G434TC61Wassenburg® Transport Cart TC-6TC-62023-07-06
PPS83S6Pre-Processing Sink83-S62017-10-31
PPS83S8Pre-Processing Sink83-S8 2017-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20840113298758CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-20
10840113298638CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113299482CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298642CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298765CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298772CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298796CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298802CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298819CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298895CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298901CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298994CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299007CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299014CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299021CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299052CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299083CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299090CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299106CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299120CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299151CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113298928CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
10840113298980CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298932CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298949CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298956CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298963CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298970CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113299168CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
00814707023824CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10