FDA.reportPublic FDA data

AADCO

Primary DI
00840348525779
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
DB-2820N
Catalog number
DB-2820N
Device description
"BAND BAG 28""X20"" NON-STERILE (100/CS) "
Published
2022-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IWQCurtain, Protective, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWQCurtain, Protective, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348525779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348525779008403485257798403485257790840348525779

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153603204
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
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348507409AADCOPB-200PB-2002022-12-07
00840348507416AADCOPB-201PB-2012022-12-07
00840348507454AADCOPB-206PB-2062022-12-07
00840348507461AADCOPB-207PB-2072022-12-07
00840348524185AADCOP-302P-3022022-12-07
00840348524192AADCOP-303P-3032022-12-07
00840348524208AADCOP-305P-3052022-12-07
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348506259AADCOP-306P-3062022-12-07
00840348506709AADCOPB-121PB-1212022-12-07
00840348506716AADCOPB-121CPB-121C2022-12-07
00840348506723AADCOPB-122PB-1222022-12-07
00840348506730AADCOPB-122CPB-122C2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061871169IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871176IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871183IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871190IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00850061871206IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.IWQ2025-04-29
00840348525564AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525571AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525588AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525595AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525601AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525618AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525625AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525670AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525687AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525717AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525724AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525731AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525748AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525755AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525786AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525793AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525809AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525816AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525823AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525830AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525847AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525854AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525861AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525878AADCOAADCO MEDICAL, INC.IWQ2022-12-19
00840348525885AADCOAADCO MEDICAL, INC.IWQ2022-12-19