FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044208054
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
222-8602-01A
Catalog number
222-8602-01A
Device description
95 PIN 2-SPLIT INOC ASSEM
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
JTCDEVICE, MICROTITER DILUTING/DISPENSING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTCDevice, Microtiter Diluting/DispensingMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044208054PrimaryGS10
00810044208269Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044208054008100442080548100442080540810044208054
00810044208269008100442082698100442082690810044208269

GMDN Terms#

Term, Definition table
TermDefinition
Inoculating tool IVD, analyser/instrumentA component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
098203461
Device count
50
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58059796363919Slide Prep Evo™COPAN WASP SRLJTC2026-02-26
58059796363926Pipettor ModuleCOPAN WASP SRLJTC2026-02-26
00382904469733BD Kiestra™ InoqulABD Kiestra B.V.JTC2025-02-18
58059796363506WASP®COPAN WASP SRLJTC2024-11-21
00810044208047Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208061Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208078Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208252Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208269Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208276Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208283Caplugs/EvergreenCAPlugsJTC2024-05-31
08800066300111ASFA® SPOTTERMBD CO., Ltd.JTC2023-11-21
06936895300083BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300090BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300106BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300113BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300076BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-04
03610520010877BIO RADBIO-RAD LABORATORIES, INC.JTC2023-02-03
00848838022333REMELREMEL, INC.JTC2023-01-03
15099590655532MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590655549MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590655556MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590702052MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590658236MicroScanBeckman Coulter, Inc.JTC2022-11-15
00894175000497Diagnostic AutomationDiagnostic Automation, Inc.JTC2021-09-16
58050148211414WASP®COPAN WASP SRLJTC2021-04-27
58050148218277Pipettor ModuleCOPAN WASP SRLJTC2021-04-27
58050148218970Slide Prep Evo™COPAN WASP SRLJTC2021-04-27
58052870813669Collaborative StationCOPAN WASP SRLJTC2021-04-27
08800066300012ASFA SPOTTERMBD CO., Ltd.JTC2020-01-29