FDA.reportPublic FDA data

Caplugs/Evergreen

Primary DI
00810044208337
Brand
Caplugs/Evergreen
Company
CAPlugs
Model
221-3995-G80
Catalog number
221-3995-G80
Device description
SPUTOCOL SPUTUM COLLECT FRSTND
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
LIODevice, specimen collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044208122PrimaryGS10
00810044208337Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044208122008100442081228100442081220810044208122
00810044208337008100442083378100442083370810044208337

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
098203461
Device count
72
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

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Primary DI, Brand, Company table
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00609576901775Puritan® OptiSwab®Puritan Medical ProductsLIO2026-07-08
00884999051690simpli-COLLECTABBOTT MOLECULAR INC.LIO2026-04-13
38053326011826BD FCTCOPAN ITALIA SPALIO2026-01-26
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05060441760043binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760033binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760040binx ioBINX HEALTH LIMITEDLIO2025-09-03
00848838066665Amies Clear Gel,Single Swab PK/500REMEL, INC.LIO2025-06-18
00848838066672Amies Clear Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
00848838066689Amies Clear Gel,Dual Swab PK/500REMEL, INC.LIO2025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50REMEL, INC.LIO2025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100REMEL, INC.LIO2025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50REMEL, INC.LIO2025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
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38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011710UriSponge™COPAN ITALIA SPALIO2025-03-12
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