FDA.reportPublic FDA data

Daye

Primary DI
05060994741018
Brand
Daye
Company
TAMPON INNOVATIONS LTD OOD
Model
FG-TMP-RET00001800
Catalog number
FG-TMP-RET00001800
Device description
Retail pack - 18 organic tampons- Regular
Published
2024-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223883000Daye TamponAnnes Daye, Ltd.2023-08-18HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060994740639PackageGS136In Commercial Distribution
05060994740578PrimaryGS10
05060994741056PrimaryGS10
05060994741063PrimaryGS10
05060994741087PrimaryGS10
05060994741018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060994740639050609947406395060994740639
05060994740578050609947405785060994740578
05060994741056050609947410565060994741056
05060994741063050609947410635060994741063
05060994741087050609947410875060994741087
05060994741018050609947410185060994741018

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight151Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999hello@yourdaye.com
+359886536143hello@yourdaye.com

Regulatory Flags#

DUNS number
524392286
Device count
18
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
05060994740554DayeFG-TMP-RET090000002024-07-24
05060994740561DayeFG-TMP-RET000900002024-07-24
05060994740592DayeFG-TMP-RET090009002024-07-24
05060994741148DayeFG-TMP-REF180000002024-07-27
05060994741155DayeFG-TMP-MM-REF360000002024-07-27
05060994741162DayeFG-TMP-MM-IB360000002024-07-27
05060994741179DayeFG-TMP-REF001800002024-07-27
05060994741186DayeFG-TMP-MM-REF003600002024-07-27
05060994741193DayeFG-TMP-MM-IB003600002024-07-27
05060994741209DayeFG-TMP-REF090900002024-07-27
05060994741216DayeFG-TMP-MM-REF181800002024-07-27
05060994741223DayeFG-TMP-MM-IB181800002024-07-27
05060994741230DayeFG-TMP-REF090009002024-07-27
05060994741247DayeFG-TMP-MM-REF1800182024-07-27
05060994741254DayeFG-TMP-MM-IB180018002024-07-27
05060994741261DayeFG-TMP-REF000900092024-07-27
05060994741278DayeFG-TMP-MM-REF001800182024-07-27
05060994741285DayeFG-TMP-MM-IB00180018002024-07-27
05060994741308DayeFG-TMP-MM-REF090909092024-07-27
05060994741315DayeFG-TMP-MM-IB090909092024-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195893628032Organic Light Tampons-8ctTPC Inc.HEB2026-05-28
00195893724130Organic Super Tampons-8ctTPC Inc.HEB2026-05-28
00195893932832Organic Regular Tampons-8ctTPC Inc.HEB2026-05-28
00196852297061Organic Light Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852637379Organic Super Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852929245Organic Regular Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00860010723173Organic Regular Tampons-550ctTPC Inc.HEB2026-05-28
00860012610303Organic Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860012610310Organic Regular Tampons-16ctTPC Inc.HEB2026-05-28
00860013110925Organic Super Tampons-16ctTPC Inc.HEB2026-05-28
00860013110932Organic Light Tampons-16ctTPC Inc.HEB2026-05-28
00860013110956Organic Light Tampons-24ctTPC Inc.HEB2026-05-28
00860013110963Organic Super Tampons-24ctTPC Inc.HEB2026-05-28
00860014539909Organic Multi Super and Super Plus Tampons-16ctTPC Inc.HEB2026-05-28
00860014539916Organic Multi Light Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860014539961Organic Light Tampons-36ctTPC Inc.HEB2026-05-28
00860014539978Organic Regular Tampons-36ctTPC Inc.HEB2026-05-28
00860014539985Organic Super Tampons-36ctTPC Inc.HEB2026-05-28
00860014539992Organic Multi Regular and Super Tampons-36ctTPC Inc.HEB2026-05-28
00860015263407Organic Multi Super and Super Plus Tampons-36ctTPC Inc.HEB2026-05-28
00860015263414Organic Multi Light Regular and Super Tampons-36ctTPC Inc.HEB2026-05-28
00860015263445Organic Super Plus Tampons-36ctTPC Inc.HEB2026-05-28
00860012610389Organic Regular Tampons-24ctTPC Inc.HEB2026-05-14
00860012610372Organic Multi Regular and Super Tampons-24ctTPC Inc.HEB2026-05-13
00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
10198926000307BIOPURE Quest USA Corp.HEB2025-03-01
10198926000314BIOPURE Quest USA Corp.HEB2025-03-01
10198926000338BIOPURE Quest USA Corp.HEB2025-03-01
10198926000352BIOPURE Quest USA Corp.HEB2025-03-01