FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044208283
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
222-8122-01T
Catalog number
222-8122-01T
Device description
2-SPLIT INOCULUM TRAY
Published
2024-05-31
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

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
00810044208078PrimaryGS10
00810044208283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044208078008100442080788100442080780810044208078
00810044208283008100442082838100442082830810044208283

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098203461
Device count
60
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810044208054Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208061Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208078Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208252Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208269Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208276Caplugs/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