FDA.reportPublic FDA data

Merit® Kit

Primary DI
00884450276990
Brand
Merit® Kit
Company
Merit Medical Systems, Inc.
Model
00884450276990
Catalog number
K14-00059
Published
2016-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEVDialysis Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEVDialysis Administration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450276997PackageGS11In Commercial Distribution
20884450276994PackageGS130In Commercial Distribution
00884450276990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445027699710884450276997
2088445027699420884450276994
00884450276990008844502769908844502769900884450276990

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter introduction setA collection of sterile devices, which includes at least one invasive device, intended to assist percutaneous placement of a peritoneal dialysis catheter (not included). The kit includes devices intended to assist catheter insertion (e.g., dilators, insertion sheath) and may include additional non-dedicated catheterization support devices (e.g., dressings); it does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

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

Regulatory Flags#

DUNS number
184763290
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450254677Merit Medical®Initial ReleaseK12-082752026-10-29
00884450838129Prelude Roadster™APG6F45MP2026-10-29
10884450708443Prelude®FPSI-7F-11-035-18G2026-10-29
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19
10884450114770Prelude IDeal™HPID5F11021PW2026-06-20
10884450115982Prelude IDeal™HPID7F16021PW2026-09-15
10884450118679Prelude EASE™JPHR4F7018SC2026-10-27
10884450438517Prelude® PROJPRO-7F-11-035MT2026-09-15
10884450438586Prelude® PROJPRO-8F-11-035MT2026-09-15
10884450439439Prelude IDeal™JPID4F7018NTPD2026-09-01
10884450451141Prelude SNAP™DPLS-10072026-09-12
10884450451783Prelude SNAP™DPLS-10062026-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956467248CARDINAL HEALTHCardinal Health 200, LLCPEV2026-07-20
10809160520291Clear SequenceMEDICAL ACTION INDUSTRIES INC.PEV2026-04-28
10198956419100CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
50198956419108CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
10809160508428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
20809160508425Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
10198459467608MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
40198459467609MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
10198459394973MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
40198459394974MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
10198459337536MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459337537MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
10198459329401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
40198459329402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
10198459283796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
40198459283797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
10653160998808Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
40653160998809Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
10197106795675CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
50197106795673CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
10198459149375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10198459149382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149383Medline 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
40195327571123Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327594023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327653460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
40195327653461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05