FDA.reportPublic FDA data

RELIEEV

Primary DI
04719894370972
Brand
RELIEEV
Company
LI Medical Corporation LT
Model
PFSCU00C1
Published
2026-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

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
K031463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031463000MARINA MEDICAL SILICONE PESSARYMarina Medical Instruments, Inc.2003-11-18HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719894370972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894370972047198943709724719894370972

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic-organ-supporting pessaryA device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

Regulatory Flags#

DUNS number
657802692
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719894370811RELIEEVPFSS01C12026-08-23
04719894370897RELIEEVPFSCP00C12026-08-23
04719894370903RELIEEVPFSCP01C12026-08-23
04719894370910RELIEEVPFSCP02C12026-08-23
04719894370927RELIEEVPFSCP03C12026-08-23
04719894370934RELIEEVPFSCP04C12026-08-23
04719894370941RELIEEVPFSCP05C12026-08-23
04719894370958RELIEEVPFSCP06C12026-08-23
04719894370965RELIEEVPFSCP07C12026-08-23
04719894370989RELIEEVPFSCU01C12026-08-23
04719894370996RELIEEVPFSCU02C12026-08-23
04719894371009RELIEEVPFSCU03C12026-08-23
04719894371016RELIEEVPFSCU04C12026-08-23
04719894371023RELIEEVPFSCU05C12026-08-23
04719894371030RELIEEVPFSCU06C12026-08-23
04719894371047RELIEEVPFSCU07C12026-08-23
04719894371054RELIEEVPFSCU08C12026-08-23
04719894371061RELIEEVPFSCU09C12026-08-23
04719894371078RELIEEVPFSCU10C12026-08-23
04719894371085RELIEEVPFSDISS00C12026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894370811RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370897RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370903RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370910RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370927RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370934RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370941RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370958RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370965RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370989RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894370996RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371009RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371016RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371023RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371030RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371047RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371054RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371061RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371078RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371085RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371092RELIEEVLI Medical Corporation LTHHW2026-08-23
04719894371108RELIEEVLI Medical Corporation LTHHW2026-08-23
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
04719894371184RELIEEVLI Medical Corporation LTHHW2026-08-23