Daye

Primary DI
05060994741322
Brand
Daye
Company
TAMPON INNOVATIONS LTD OOD
Model
FG-TMP-REF00000909
Device description
9 Organic Cotton Regular and 9 Organic Cotton Super Tampons
Published
2024-07-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
05060994741322PrimaryGS10
55060994741327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060994741322050609947413225060994741322
5506099474132755060994741327

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.

Regulatory Flags#

DUNS number
524392286
Device count
18
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
05060994740752DayeFG-TMP-RET000054002026-09-25
05060994740769DayeFG-TMP-RET000000542026-09-25
05060994740165DayeFG-VMS-ES2024-07-27
05060994740318DayeFG-VMS-ES2024-07-27
05060994741001DayeFG-VMS-ES2024-07-27
05060994741070DayeFG-TMP-REF000009092024-07-24
05060994741117DayeFG-TMP-MM-IB000000362024-07-27
05060994741124DayeFG-TMP-MM-REF000018182024-07-27
05060994741131DayeFG-TMP-MM-IB000018182024-07-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
00036000602579KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602586KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602593KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602647KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
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