FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044208030
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
201-5266-05SF
Catalog number
201-5266-05SF
Device description
DILUTION VIAL, TRAY PK 5X50
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
JKHHYDRAZONE DERIV. OF ALPHA-KETOGLUTERATE (COLORIMETRY), ISOCITRIC DEHYDROGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKHHydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric DehydrogenClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044208030PrimaryGS10
00810044208245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044208030008100442080308100442080300810044208030
00810044208245008100442082458100442082450810044208245

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. 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
250
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
00810044208009Caplugs/EvergreenCAPlugsJKH2024-05-31
00810044208016Caplugs/EvergreenCAPlugsJKH2024-05-31
00810044208023Caplugs/EvergreenCAPlugsJKH2024-05-31
00810044208214Caplugs/EvergreenCAPlugsJKH2024-05-31
00810044208221Caplugs/EvergreenCAPlugsJKH2024-05-31
00810044208238Caplugs/EvergreenCAPlugsJKH2024-05-31
00810044208245Caplugs/EvergreenCAPlugsJKH2024-05-31