FDA.reportPublic FDA data

HEMO-TAP

Primary DI
H67140205090
Brand
HEMO-TAP
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Bag Spike
Catalog number
4020509
Device description
Blood Bag Spike with Injection Site
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
FPBFilter, Infusion Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781815000HEMO-NATE SYRINGE BLOOD FILTERGisco Intl.1979-02-27FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H67140205091PackageHIBCC30In Commercial Distribution
H67140205090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion filterA microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. 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
46975124930965 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.FPB2026-04-11
00859695006084WalkMed InfusionWALKMED TECHNOLOGIES, LLCFPB2025-09-12
00849884006179VYGONVygon CorporationFPB2023-06-05
00849884006186VYGONVygon CorporationFPB2023-06-05
30849884006170VYGONVygon CorporationFPB2023-06-05
30849884006187VYGONVygon CorporationFPB2023-06-05
08426314391399GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
28426314391416GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
00849884005035VYGONVygon CorporationFPB2021-01-22
00849884005042VYGONVygon CorporationFPB2021-01-22
30849884005036VYGONVygon CorporationFPB2021-01-22
30849884005043VYGONVygon CorporationFPB2021-01-22
00085412639338EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-10-21
00085412639444FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412653297EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412660387EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
50085412639449FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
10849884002604VYGONVygon CorporationFPB2020-04-01
30849884002608VYGONVygon CorporationFPB2020-04-01
00849884004328VYGONVygon CorporationFPB2020-01-27
30849884004329VYGONVygon CorporationFPB2020-01-27
00849884000337VYGONVygon CorporationFPB2019-12-16
30849884000338VYGONVygon CorporationFPB2019-12-16
00849884000504VYGONVygon CorporationFPB2019-11-14
30849884000505VYGONVygon CorporationFPB2019-11-14
00849884002775VYGONVygon CorporationFPB2019-11-01
30849884002776VYGONVygon CorporationFPB2019-11-01