FDA.reportPublic FDA data

Wellness

Primary DI
00819835023425
Brand
Wellness
Company
Blush Novelties
Model
Wellness - Dilator Kit - Purple
Catalog number
BL-444111
Device description
Wellness - Dilator Kit - PurplePart Number: BL-444111Material Type: Silicone
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819835023425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819835023425008198350234258198350234250819835023425

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057027601
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002870800BlushBlush Lube - Water-Based - 4 FL Oz.BL-100492025-09-26
00850002870718Performance PlusPerformance Plus - Flex Pro - BlueBL-900022025-03-17
00850002870725Performance PlusPerformance Plus - Dual Flex Pro - BlueBL-900122025-03-17
00810138370834DeliceDelice - Chéri - Kegel Trainer - PurpleBL-237212025-03-13
00850002870619Performance PlusPerformance Plus - Throttle - BlackBL-920052025-02-14
00850002870626Performance PlusPerformance Plus - Engage - Black / BlueBL-920022025-02-14
00850002870633Performance PlusPerformance Plus - Accelerate - BlackBL-920152025-02-14
00850002870640Performance PlusPerformance Plus - Pursuit - RedBL-920082025-02-14
00850002870657Performance PlusPerformance Plus - Traction - BlackBL-920252025-02-14
00850002870664Performance PlusPerformance Plus - Drift - BlackBL-920352025-02-14
00850002870671Performance PlusPerformance Plus - Flash - MultiBL-920222025-02-14
00850002870688Performance PlusPerformance Plus - Takeoff - Red/BlackBL-922222025-02-14
00850002870695Performance PlusPerformance Plus - Flare - Black / NeonckBL-923222025-02-14
00850002870701Performance PlusPerformance Plus - Launch - BlackBL-920452025-02-14
00819835024125WellnessWellness - Kegel Training Kit - PurpleBL-4440042025-01-28
00850002870565Play With MePlay With Me - Pleaser Rechargeable C-Ring - Neon BL-316222024-12-13
00850002870572Play With MePlay With Me - Pleaser Rechargeable C-Ring - PinkBL-316102024-12-13
00853858007383Stay HardStay Hard - Beaded Cock Rings - BlackBL-000152022-12-06
00853858007451Stay HardStay Hard - Donut Rings - 50 Piece Display EditBC-0082022-12-06
00853858007611Play With MePlay With Me - Stretch C-Ring - 50 piecesBC-0092022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093180ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
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00860011927686Monarch Medical ProductsBioteque Taiwan Ltd.HDQ2026-07-24
04719894436517LTL MedicalBioteque Taiwan Ltd.HDQ2026-07-24
00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093708ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093715ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093722ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092473ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092480ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092497ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00348783011265Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011272Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011289Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432458BiotequeBioteque Taiwan Ltd.HDQ2024-04-08