FDA.reportPublic FDA data

Dynacare HerCare Necessities Complete Kit

Primary DI
00840117343788
Brand
Dynacare HerCare Necessities Complete Kit
Company
Dynarex Corporation
Model
1375
Device description
Kit Contents: 2 Maxi Pads Super w/Wings 2 Maxi Pads Ultra Thin w/Wings 2 Feminine Hygiene Wipes
Published
2026-05-29
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

Product Codes#

Code, Name table
CodeName
PVTMaternity Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVTMaternity KitObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117343771PackageGS150In Commercial Distribution
00840117343788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117343771008401173437718401173437710840117343771
00840117343788008401173437888401173437880840117343788

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual pad, unscentedA non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
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
true
Sterilization required before use
false

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25
00840117352162AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67232019-11-25
00840117352186AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67242019-11-25
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,89402018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, Sterile89412018-05-26
00616784894225LabChoice SecureSafety Safety Blood Collection Sets, Sterile89422018-05-26
00616784010014Aluminum Crutches - Child101002019-09-30
00840117346505PA Safety Lancets, Pressure Activated, 21 G Needle71132026-06-01
00616784213132Shoe Cover Non-Conductive, Universal21312021-06-21
00616784213231Shoe Cover Non-Conductive, Non-Skid, Universal Size21322021-06-21
00616784213439Shoe Cover Non-Conductive, Non-Skid, X-Large21342021-06-21
00616784426518IV Pole Kit For Enteral Irrigation, Non-Sterile42652021-09-01
00616784562018DynaLift Transport Unit, White, 40" x 80" (101.6 cm x 203.2 cm)56202021-04-22
00616784562117DynaLift Transport Unit, Black, 40" x 80" (101.6 cm x 203.2 cm)56212021-04-22
00840117308992Resp-O2 Single Suction Catheter, 12 FR320032022-05-10
00840117309012Resp-O2 Single Suction Catheter, 14 FR320042022-05-10
00840117309036Resp-O2 Single Suction Catheter, 16 FR320052022-05-10
00840117309050Resp-O2 Single Suction Catheter, 18 FR320062022-05-10
00840117310285Resp-O2 Single Suction Catheter, 6 FR320002022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117343764Dynacare Necessities Complete KitDynarex CorporationPVT2026-05-28