FDA.reportPublic FDA data

BT-CATH

Primary DI
H671BTCESY0
Brand
BT-CATH
Company
UTAH MEDICAL PRODUCTS, INC.
Model
EasyFill
Catalog number
BTC-ESY
Device description
Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage with EasyFill Inflation System
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQYIntrauterine Tamponade Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQYIntrauterine Tamponade BalloonObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101535000BT-CATHUtah Medical Products, Inc.2011-01-11OQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671BTCESY1PackageHIBCC2In Commercial Distribution
H671BTCESY0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine haemostatic balloon catheterA sterile, flexible tube with an inflatable balloon at its distal end intended to be inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure. It may have an additional balloon inflated in the upper vagina to seal the uterine cavity. Devices associated with balloon inflation may be included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
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
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937027846Bakri®Coopersurgical, Inc.OQY2025-12-10
00888937027853Bakri®Coopersurgical, Inc.OQY2025-12-10
00827002590946BakriCOOK INCORPORATEDOQY2023-02-28
10827002590943BakriCOOK INCORPORATEDOQY2023-02-28
00840164521139JADA SystemOrganon LLCOQY2023-02-15
60840164521131JADA SystemOrganon LLCOQY2023-02-15
00850017882003Jada™ SystemAlydia Health, Inc.OQY2020-10-15
10827002242378BakriCOOK INCORPORATEDOQY2016-09-24
10827002306735BakriCOOK INCORPORATEDOQY2016-09-24
H671BTC1000BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTC1001BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTCESY1BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
00814247020765Ebb® Complete Tamponade SystemCLINICAL INNOVATIONS, LLCOQY2016-09-01