FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044208375
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
127-1758-B20
Catalog number
127-1758-B20
Device description
SERUM S CUP FOR ROCHE BIO MIRA FARA
Published
2026-02-06
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
JJCANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044208351PrimaryGS10
00810044208375Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044208351008100442083518100442083510810044208351
00810044208375008100442083758100442083750810044208375

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser cuvette IVD, single-useA small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use 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
1000
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
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
00810044206777Caplugs/Evergreen208-3392-060208-3392-0602024-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810044208351Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044208368Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044208382Caplugs/EvergreenCAPlugsJJC2026-02-06
00810044200959Caplugs/EvergreenCAPlugsJJC2020-10-14
00810044200607Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200614Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200621Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200638Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200645Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200652Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200669Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200676Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200683Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200690Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200829Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200836Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200843Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200850Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200867Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200874Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200881Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200898Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200904Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200911Caplugs/EvergreenCAPlugsJJC2020-07-02
00810044200522Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200539Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200546Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200553Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200560Caplugs/EvergreenCAPlugsJJC2020-06-19
00810044200577Caplugs/EvergreenCAPlugsJJC2020-06-19