FDA.reportPublic FDA data

FemCath

Primary DI
00859500005035
Brand
FemCath
Company
FEMASYS INC.
Model
CBC-100
Catalog number
02827
Device description
FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray)
Published
2022-04-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100662000FEMVUE CORNUAL BALLOON CATHETERFemasys, Inc.2010-04-07LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859500005035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859500005035008595000050358595000050350859500005035

GMDN Terms#

Term, Definition table
TermDefinition
Salpingographic catheterA flexible, balloon-tipped tube inserted transvaginally and through the uterus for the selective catheterization/cannulation of the fallopian tubes, in order to inject dye or a contrast medium into the tubes for a radiographic procedure; it is usually radiopaque. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147590330
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859500005288FemSperm Analyzer FSP-500054472026-02-06
00859500005318FemSperm Pack AnalysisFSP-400054442026-02-06
00859500005325FemSperm No AnalysisFSP-401054452026-02-06
00859500005349FemSperm Pack AnalysisFSP-402055492026-02-06
00859500005356FemSperm No AnalysisFSP-403055502026-02-06
20859500005008FemVueFSA-2002026-01-06
30859500005005FemVueFSA-2002026-01-06
20859500005169StopLockSLK-100043912025-05-02
10859500005162StopLockSLK-100043902025-05-02
00859500005165StopLockSLK-100043912025-05-02
30859500005166StopLockSLK-100043922025-05-02
00859500005097FemChec FCD-2502024-09-16
00859500005080FemCathCBC-150041942023-06-06
00859500005127VariLockVL-1001041782024-03-13
00859500005103FemaSeedFDI-2002024-01-22
20859500005107FemaSeedFDI-2002023-11-28
30859500005104FemaSeedFDI-2002023-11-29
10859500005100FemaSeedFDI-2002023-11-28
10859500005018FemaSeedFDI-2002023-11-28
00859500005011FemaSeedFDI-2002023-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
00850011427385TITUS MEDICALTITUS MEDICAL LLCLKF2026-04-19
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00888937029697ALLY II UPS (Uterine Positioning System)Coopersurgical, Inc.LKF2025-12-18
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835377Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835384Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835391Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
04719894432892BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432908BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432915BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432922BiotequeBioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432779BiotequeBioteque Taiwan Ltd.LKF2024-04-08