FDA.reportPublic FDA data

CMI

Primary DI
H671303TTL0
Brand
CMI
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Tender Touch Cup
Catalog number
303TTL
Device description
OBSTETRICAL VACUUM DELIVERY KIT, 65 mm Tender Touch Ultra Cup, Tube, & Fluid Trap
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDBExtractor, Vacuum, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDBExtractor, Vacuum, FetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910788000CMI TENDER TOUCH VE #303TT AND 404TTChallenge Mfg., Inc.1991-05-09HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671303TTL1PackageHIBCC10In Commercial Distribution
H671303TTL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Foetal vacuum extraction system cup, single-useA suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or maternal/foetal distress. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter65Millimeter

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
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
H671IUP5500INTRANPlusIUP-5502016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021243Kiwi® OmniCup®CLINICAL INNOVATIONS, LLCHDB2025-12-16
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGHDB2024-05-31
07612367003551Quiver 280mmMedela AGHDB2024-05-31
07612367003568Quiver 480mmMedela AGHDB2024-05-31
07612367003575Change over valveMedela AGHDB2024-05-31
07612367003698Overflow protection deviceMedela AGHDB2024-05-31
07612367003735Reusable serial connectorMedela AGHDB2024-05-31
07612367003742Safety Set for railholderMedela AGHDB2024-05-31
07612367003896Tubing holder left sideMedela AGHDB2024-05-31
07612367003902Tubing holder right sideMedela AGHDB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGHDB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGHDB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGHDB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGHDB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGHDB2024-05-31
07612367008242Double conical coupling pieceMedela AGHDB2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGHDB2024-05-31
07612367009928Y-pieceMedela AGHDB2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGHDB2024-05-31
07612367011372Single set 1lMedela AGHDB2024-05-31
07612367011389Single set 2lMedela AGHDB2024-05-31
07612367011600Single set 2l, clampholderMedela AGHDB2024-05-31
07612367017329Single set 1l, clampholderMedela AGHDB2024-05-31
07612367017336Single set 3l, clampholderMedela AGHDB2024-05-31
07612367017343Single set 5l, clampholderMedela AGHDB2024-05-31
07612367017350Double set 3lMedela AGHDB2024-05-31
07612367017367Double set 5lMedela AGHDB2024-05-31
07612367038225Double set 2lMedela AGHDB2024-05-31
07612367047692Trolley A for DCSMedela AGHDB2024-05-31
07612367051033Trolley B for DCSMedela AGHDB2024-05-31