FDA.reportPublic FDA data

Revive

Primary DI
00854389008009
Brand
Revive
Company
RINOVUM SUBSIDIARY 2, LLC
Model
0025
Catalog number
0025
Device description
The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
Published
2019-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPessary, Vaginal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183468000Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC2019-01-25HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854389008023PackageGS12In Commercial Distribution
00854389008054PackageGS11In Commercial Distribution
10854389008020PackageGS116In Commercial Distribution
20854389008027PackageGS16In Commercial Distribution
00854389008009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854389008023008543890080238543890080230854389008023
00854389008054008543890080548543890080540854389008054
1085438900802010854389008020
2085438900802720854389008027
00854389008009008543890080098543890080090854389008009

GMDN Terms#

Term, Definition table
TermDefinition
Urinary-incontinence vaginal insert, reusableA 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 reusable device - after appropriate cleaning - intended for single-patient use.

Contacts#

Phone, Email table
PhoneEmail
866-786-7525info@userevive.com

Regulatory Flags#

DUNS number
081362926
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20854389008027Revive002500252019-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894432083BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432090BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432106BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432137BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432144BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432151BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432168BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432175BiotequeBioteque Taiwan Ltd.HHW2026-09-02
04719894432113BiotequeBioteque Taiwan Ltd.HHW2026-09-01
04719894432120BiotequeBioteque Taiwan Ltd.HHW2026-09-01
00810142350334Bioteque America, Inc.Bioteque America, Inc.HHW2025-06-02
00810142350587Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350594Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350600Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350617Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350624Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350631Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350648Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350655Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350662Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350679Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350686Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350693Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350709Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350716Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350723Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350730Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350754Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350761Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29
00810142350778Bioteque America, Inc.Bioteque America, Inc.HHW2025-05-29