FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095602266
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
1300
Device description
Diamond PerfectSmear, Blood Smearing Tool, 72/Box
Published
2019-11-27
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
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840095602273PackageGS150In Commercial Distribution
00840095602266PrimaryGS10
00840095609654Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095602273008400956022738400956022730840095602273
00840095602266008400956022668400956022660840095602266
00840095609654008400956096548400956096540840095609654

GMDN Terms#

Term, Definition table
TermDefinition
Blood smear instrument IVD, manualA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106793995
Device count
72
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840095681674Globe ScientificGCC-P2026-03-16
00840095688840Globe Scientific 154005R2025-07-07
00840095688857Globe Scientific 154020R2025-07-07
00840095688864Globe Scientific 154035R2025-07-07
00840095688871Globe Scientific 154005RS2025-07-07
00840095688888Globe Scientific 154020RS2025-07-07
00840095688895Globe Scientific 154035RS2025-07-07
00840095688901Globe Scientific 154105RS2025-07-07
00840095688918Globe Scientific 154120RS2025-07-07
00840095688925Globe Scientific 154135RS2025-07-07
00840095688932Globe Scientific 154205RS2025-07-07
00840095688949Globe Scientific 154220RS2025-07-07
00840095688956Globe Scientific 154235RS2025-07-07
00840095688994Globe Scientific 154005F2025-07-07
00840095689007Globe Scientific 154020F2025-07-07
00840095689014Globe Scientific 154035F2025-07-07
00840095689021Globe Scientific 154005FS2025-07-07
00840095689038Globe Scientific 154020FS2025-07-07
00840095689045Globe Scientific 154035FS2025-07-07
00840095689052Globe Scientific 154105FS2025-07-07

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Primary DI, Brand, Company table
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00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
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00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
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00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
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20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18