FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450169954
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450169957
Catalog number
VP-411/A
Published
2018-02-16
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
GBWCATHETER, PERITONEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450169954PackageGS130In Commercial Distribution
00884450169957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445016995410884450169954
00884450169957008844501699578844501699570884450169957

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50749756035243DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-08
50749756035755DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-03
20801902197942ARROWTELEFLEX INCORPORATEDGBW2022-11-09
10653405050032CORE DYNAMICSConmed CorporationGBW2022-06-02
04710961935865Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935872Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935889Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935896Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935902Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605810Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605827Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605759Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935858Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-11-24
14543527251959Super Sheath CBDETOGO MEDIKIT CO.,LTD.GBW2021-05-14
M368395310GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953120GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953140GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953340GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953580GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
00827002026254CookCOOK INCORPORATEDGBW2020-10-02
00827002043855CookCOOK INCORPORATEDGBW2020-10-02
00827002052673CookCOOK INCORPORATEDGBW2020-10-02
00827002052680CookCOOK INCORPORATEDGBW2020-10-02
20801902162926ARROWTELEFLEX INCORPORATEDGBW2020-04-28
34026704656456TAUTTELEFLEX INCORPORATEDGBW2019-06-03
24026704656466TAUTTELEFLEX INCORPORATEDGBW2019-06-03
34026704656470TAUTTELEFLEX INCORPORATEDGBW2019-06-03
00801902005243ARROWTELEFLEX INCORPORATEDGBW2019-03-07
34026704656487TAUTTELEFLEX INCORPORATEDGBW2019-02-28
20801902121725ARROWTELEFLEX INCORPORATEDGBW2018-10-25