FDA.reportPublic FDA data

BMP 10 CHAMBER ACRYLIC SLIDE (Decislide)

Primary DI
10853778007163
Brand
BMP 10 CHAMBER ACRYLIC SLIDE (Decislide)
Company
Biomedical Polymers, Inc.
Model
BMP-SLIDE-10
Published
2023-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KEWSlides, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853778007163PackageGS150In Commercial Distribution
20853778007160PackageGS1500In Commercial Distribution
00853778007166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085377800716310853778007163
2085377800716020853778007160
00853778007166008537780071668537780071660853778007166

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037687837
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853778007128HEMODROP BLOOD DISPENSERBMP-HEMODROP2023-08-22
10853778007125HEMODROP BLOOD DISPENSERBMP-HEMODROP2023-08-22
00853778007005Double Cytology Funnel w/ White Card and CapsBMP-CYTO-DB252023-08-21
00853778007081BMP Medical Tissue GrinderBMP-TG-7022023-08-21
00853778007104BMP Medical Tissue Grinder (Vitrified Tip)BMP-TG-7062023-08-21
00853778007111BMP Medical Tissue Grinder (Vitrified Tip)BMP-TG-7082023-08-21
00853778007135BMP Medical Single Cytology Funnel w/ White CardBMP-CYTO-S502023-08-21
00853778007142Single Cytology Funnel w/ Brown CardBMP-CYTO-S50BP2023-08-21
00853778007159BMP Medical Metal Cytology ClipBMP-FUNNEL-CLIP2023-08-21
00853778007166BMP 10 CHAMBER ACRYLIC SLIDE (Decislide)BMP-SLIDE-102023-08-21
20853778007009Double Cytology Funnel w/ White Card and CapsBMP-CYTO-DB252023-08-21
00853778007074BMP Medical Tissue GrinderBMP-TG-7002023-08-21
10853778007088BMP Medical Tissue GrinderBMP-TG-7022023-08-21
00853778007098BMP Medical Tissue GrinderBMP-TG-7042023-08-21
10853778007101BMP Medical Tissue Grinder (Vitrified Tip)BMP-TG-7062023-08-21
10853778007118BMP Medical Tissue Grinder (Vitrified Tip)BMP-TG-7082023-08-21
10853778007132BMP Medical Single Cytology Funnel w/ White CardBMP-CYTO-S502023-08-21
10853778007149Single Cytology Funnel w/ Brown CardBMP-CYTO-S50BP2023-08-21
10853778007156BMP Medical Metal Cytology ClipBMP-FUNNEL-CLIP2023-08-21
30853778007136BMP Medical Single Cytology Funnel w/ White CardBMP-CYTO-S5002023-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855850Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855867Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855874Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855881Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855898Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855836Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124417McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124424McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124431McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160385McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160392McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160408McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
10194484321588N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321595N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321533N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321564N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321571N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321267N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321274N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321304N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321311N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321328N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321335N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321342N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20849832023214Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024174Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024310Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024327Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024358Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832025331Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23