FDA.reportPublic FDA data

Merit® Kit

Primary DI
20884450278226
Brand
Merit® Kit
Company
Merit Medical Systems, Inc.
Model
00884450278222
Catalog number
K14-00057
Published
2016-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MSDCatheter, hemodialysis, implanted
PEVDialysis Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2
PEVDialysis Administration KitGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090148000PROGUIDE CHRONIC DIALYSIS CATHETERMerit Medical Systems, Inc.2009-04-13MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450278229PackageGS11In Commercial Distribution
20884450278226PackageGS110In Commercial Distribution
00884450278222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445027822910884450278229
2088445027822620884450278226
00884450278222008844502782228844502782220884450278222

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableA sterile, implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450467572DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469033BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450469132BioFlo DuraMax®Merit Medical Systems, Inc.MSD2026-06-08
00884450794760DuraMax®Merit Medical Systems, Inc.MSD2026-06-02
10198956419100CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
10198459467608MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
10198459394973MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
10198459337536MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
10198459329401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
10198459283796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
10653160998808Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
10197106795675CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
10198459149375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10198459149382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10195327571122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327594022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327653460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
10197106506998CARDINAL HEALTHCardinal Health 200, LLCPEV2024-02-13
10195327625160Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-02-11
10195327538590Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-21
10195327544829Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-21
10653160995777Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2023-12-21
10653160995784Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2023-12-21
10195327572662Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-17
10195327572679Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-12-17
10195327531546Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
10195327535209Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
10195327535216Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-10-29
10197106403273CARDINAL HEALTHCardinal Health 200, LLCPEV2023-09-14
10195327429751Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2023-07-29