FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044207385
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
230-1595-020
Catalog number
230-1595-020
Device description
TRANS PIPET 3.5ML LONG STEM
Published
2024-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044207385PrimaryGS10
00810044207750Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044207385008100442073858100442073850810044207385
00810044207750008100442077508100442077500810044207750

GMDN Terms#

Term, Definition table
TermDefinition
Pipette tip IVDA device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(716)876-9855christine.koch@caplugs.com

Regulatory Flags#

DUNS number
098203461
Device count
400
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044208146Caplugs/Evergreen308-1000-000308-1000-0002024-05-31
00810044208153Caplugs/Evergreen308-1050-FPCSV308-1050-FPCSV2024-05-31
00810044208160Caplugs/Evergreen308-2000-000308-2000-0002024-05-31
00810044208177Caplugs/Evergreen308-4000-000308-4000-0002024-05-31
00810044208351Caplugs/Evergreen127-1758-B20127-1758-B202026-02-06
00810044208368Caplugs/Evergreen127-1758-Y20127-1758-Y202026-02-06
00810044208375Caplugs/Evergreen127-1758-B20127-1758-B202026-02-06
00810044208382Caplugs/Evergreen127-1758-Y20127-1758-Y202026-02-06
00810044206654Caplugs/Evergreen208-3366-050208-3366-0502024-05-31
00810044206661Caplugs/Evergreen208-3367-050208-3367-0502024-05-31
00810044206678Caplugs/Evergreen208-3368-050208-3368-0502024-05-31
00810044206685Caplugs/Evergreen208-3383-03K208-3383-03K2024-05-31
00810044206692Caplugs/Evergreen208-3383-060208-3383-0602024-05-31
00810044206708Caplugs/Evergreen208-3384-060208-3384-0602024-05-31
00810044206715Caplugs/Evergreen208-3385-060208-3385-0602024-05-31
00810044206722Caplugs/Evergreen208-3385-06R208-3385-06R2024-05-31
00810044206739Caplugs/Evergreen208-3385-06S208-3385-06S2024-05-31
00810044206746Caplugs/Evergreen208-3376-050208-3376-0502024-05-31
00810044206753Caplugs/Evergreen208-3377-050208-3377-0502024-05-31
00810044206760Caplugs/Evergreen208-3378-050208-3378-0502024-05-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026392Diagnostic Automation, Inc.Diagnostic Automation, Inc.JQW2025-12-24
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00884999051515Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
00884999051720Alinity mpABBOTT MOLECULAR INC.JQW2025-05-28
06975379910028QuaeroZhejiang Biorear Biotechnology Co., Ltd.JQW2025-05-14
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