FDA.reportPublic FDA data

Diva Biome Balancer Applicator

Primary DI
00841445001388
Brand
Diva Biome Balancer Applicator
Company
Diva International Inc
Model
1
Device description
Vaginal suppository applicator
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGDApplicator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGDApplicator, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841445001388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841445001388008414450013888414450013880841445001388

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal applicator, reusableA device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
207651758
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428087701The DivaCupModel B PL6348642026-03-31
00050428088852The DivaCupModel A PL7225372026-03-31
00841445001203Diva Cramp Care Patch-FGMC5402012025-11-03
00841445001326DivaCup ImpactModel 0DV0002025-09-01
00841445001333DivaCup ImpactModel 1DV0012025-09-01
00841445001340DivaCup ImpactModel 2DV0022025-09-01
00857538000015The DivaCupModel 1FGCU0101012017-07-27
00857538000022The DivaCupModel 2FGCU0201012017-07-27
00841445001111Diva Lubricator1FGBC2002012025-04-01
00841445000428Diva UnderwearXS-SFGUN060101BK012024-07-17
00841445000435Diva UnderwearM-LFGUN060101BK022024-07-17
00841445000442Diva UnderwearXL-XXLFGUN060101BK032024-07-17
00841445000459Diva Underwear3XL-4XLFGUN060101BK042024-07-17
00841445000466DivaXS-SFGUN060201BK012023-09-29
00841445000473DivaM-LFGUN060201BK022023-09-29
00841445000480DivaXL-XXLFGUN060201BK032023-09-29
00841445000497Diva3XL-4XLFGUN060201BK042023-09-29
00841445001678Diva Disc1FGCU0501012023-04-27
00857538000237The DivaCupModel 0FGCU0001012018-02-23
00050428645598The DivaCupModel A PL7225372024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015433701WandahCASCO BAY MOLDING LTD.HGD2026-05-15
10378206189018XACIATOOrganon LLCHGD2024-09-13
00860012119363ReiaReia, LLCHGD2024-07-22
00860012119370ReiaReia, LLCHGD2024-07-22
00860012119387ReiaReia, LLCHGD2024-07-22
00850016867377Pixie CupPixie Cup LLCHGD2023-11-20
00850016867728Pixie CupPixie Cup LLCHGD2023-11-20
00719113275860Vaginal ApplicatorMai/GenesisHGD2023-09-14
00338779998410Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998427Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998434Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998417Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998424Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998431Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00860009492905VCA LitePce, Inc.HGD2023-08-11
00860009492912VCA LitePce, Inc.HGD2023-08-11
00826804000516Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000523Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000530Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006914Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006938Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006945Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006952Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00813360022076DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
10813360022073DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
00813360022069DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-01
00813360021994DoselogixTEAM TECHNOLOGIES, INC.HGD2022-07-30
08057509880031NAINGE SPAHGD2022-07-17
08057509880024NAINGE SPAHGD2022-07-17
00653160055733CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-02