FDA.reportPublic FDA data

Smearsafe

Primary DI
10810050855799
Brand
Smearsafe
Company
TYPENEX MEDICAL LLC
Model
BD0101
Device description
Smearsafe™ Blood Dispenser (BD0101)
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JRCMicro Pipette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRCMicro PipetteClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810050855796PackageGS12In Commercial Distribution
10810050855799PrimaryGS10
00810050855792Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081005085579620810050855796
1081005085579910810050855799
00810050855792008100508557928100508557920810050855792

GMDN Terms#

Term, Definition table
TermDefinition
Blood smearing manual instrument IVDA manual laboratory instrument intended to be used to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. The device operates with technician involvement in most procedural steps.

Regulatory Flags#

DUNS number
600850213
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197007459cobas® Liat Transfer Pipette PackRoche Molecular Systems, Inc.JRC2026-03-26
04038917085830Haemo-Diff®Sarstedt Aktiengesellschaft & Co.KGJRC2025-09-25
00840095688840Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688857Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688864Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688871Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688888Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688895Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688901Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688918Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688925Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688932Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688949Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688956Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688994Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689007Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689014Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689021Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689038Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689045Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689052Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689069Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689076Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689083Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689090Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689106Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689113Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689120Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689137Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689144Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07