FDA.reportPublic FDA data

DIALY-NATE

Primary DI
H67140005470
Brand
DIALY-NATE
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Set
Catalog number
4000547
Device description
SET W/ ADDITIONAL BURETTE ASSEMBLY, Peritoneal Dialysis Set for Neonates
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
FKOCatheter, Peritoneal Dialysis, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKOCatheter, Peritoneal Dialysis, Single UseGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H67140005470PrimaryHIBCC0

Sterilization Methods#

Method table
Method

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
10884521811164RitusMozarc Medical US LLCFKO2026-04-20
10885403108327n/aCAREFUSION 2200, INCFKO2017-06-12
50885403108325n/aCAREFUSION 2200, INCFKO2017-06-12
10884521024281ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024298ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024311ArgyleMozarc Medical US LLCFKO2016-09-24
20884521024288ArgyleCovidien LPFKO2016-09-24
20884521024295ArgyleCovidien LPFKO2016-09-24
20884521024301ArgyleCovidien LPFKO2016-09-24
20884521024318ArgyleCovidien LPFKO2016-09-24
H67140005070DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005170DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005270DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005370DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005570DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005670DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
00898021000068Alcavis 50Angelini Pharma Inc.FKO2016-08-29
20898021000062Alcavis 50ANGELINI PHARMA INC.FKO2016-08-29
00884450170021Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
10884450170028Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
00852250006017Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
10852250006014Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
00852250006079Lifemed Pediatric Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06