FDA.reportPublic FDA data

Poise

Primary DI
00036000470598
Brand
Poise
Company
KIMBERLY-CLARK GLOBAL SALES, INC.
Model
Pessary
Device description
POISE IMPRESSA SIZE 1 BLADDER SUPPORT DEVICE
Published
2019-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPESSARY, VAGINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00036000470598PrimaryGS10
00036000998450Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00036000470598000360004705980360004705980036000470598
00036000998450000360009984500360009984500036000998450

GMDN Terms#

Term, Definition table
TermDefinition
Urinary-incontinence vaginal insert, single-useA non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width40Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)340-3102xxx@xxx.xxx

Regulatory Flags#

DUNS number
829568273
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036000602579KotexTampon2026-09-20
00036000602586KotexTampon2026-09-20
00036000602593KotexTampon2026-09-20
00036000602609KotexTampon2026-09-20
00036000602616KotexTampon2026-09-20
00036000602647KotexTampon2026-09-20
00036000602654KotexTampon2026-09-20
00036000602661KotexTampon2026-09-20
00036000606126KotexTampon2026-09-20
00036000586329U by KotexTampon; Pad2026-02-18
00036000596168U by KotexTampon; Pad2026-02-18
00036000597295U by KotexTampon; Pad2026-02-18
10036000563068U By KotexKOTEX TAMPONS2024-09-06
10036000373056U by KotexTampon2016-09-23
10036000426639U by KotexTampon2016-09-23
10036000426660U by KotexTampon2016-09-23
10036000448273U by KotexTampon2016-09-23
10036000472889U by KotexTampon2017-03-27
10036000475392U by KotexTampon2017-10-11
10036000475446U by KotexTampon2017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719894370965RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370972RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370989RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370996RELIEEVLI Medical Corporation LTHHW2026-08-23
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04719894371047RELIEEVLI Medical Corporation LTHHW2026-08-23
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04719894371061RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371078RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371085RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371092RELIEEVLI Medical Corporation LTHHW2026-08-23
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04719894371115RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371122RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371139RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371146RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371153RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371160RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371177RELIEEVLI Medical Corporation LTHHW2026-08-23