FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450727911
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450727911
Catalog number
PC801/A
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PXUFluid drainage tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXUFluid Drainage TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450727918PackageGS14In Commercial Distribution
00884450727911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445072791810884450727918
00884450727911008844507279118844507279110884450727911

GMDN Terms#

Term, Definition table
TermDefinition
Pericardiocentesis catheterA flexible tube designed for the drainage of effusion from the pericardial sac (the pericardium). It typically consists of a thin walled, flexible, plastic [e.g., polyethylene (PE)] tube with a J-shaped distal tip perforated with multiple holes in both its convex and concave sides. It is introduced percutaneously into the pericardium, anchored in place, and connected to a water-seal drainage system. It can be left in situ for some days or weeks during the treatment of cardiac tamponade and can be used for the irrigation/instillation of drugs (e.g., antibiotics, cytotoxic agents) into the pericardium. This is a single-use device.

Regulatory Flags#

DUNS number
184763290
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

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
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708265018024LiNA OperaScope™ Tubing & Drape kitLiNA Medical AGPXU2026-04-03
04046955911493ASEPTB. BRAUN MEDICAL INC.PXU2025-10-14
10198956062894CARDINAL HEALTHCardinal Health 200, LLCPXU2025-05-02
50198956062892CARDINAL HEALTHCardinal Health 200, LLCPXU2025-05-02
10197106485897CARDINAL HEALTHCardinal Health 200, LLCPXU2023-12-27
50197106485895CARDINAL HEALTHCardinal Health 200, LLCPXU2023-12-27
00884450727928Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10884450727918Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10884450727925Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10197106328750CARDINAL HEALTHCardinal Health 200, LLCPXU2023-10-12
50197106328758CARDINAL HEALTHCardinal Health 200, LLCPXU2023-10-12
10197106362990CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-31
50197106362998CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-31
10197106323458CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-06
50197106323456CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-06
10195594830410CARDINAL HEALTHCardinal Health 200, LLCPXU2022-09-14
50195594830418CARDINAL HEALTHCardinal Health 200, LLCPXU2022-09-14
00860003054949CLR MedicalCLR MedicalPXU2021-11-05
10195594131883CARDINAL HEALTHCardinal Health 200, LLCPXU2021-06-01
50195594131881CARDINAL HEALTHCardinal Health 200, LLCPXU2021-06-01
00884450486061PeriVac™ KitMerit Medical Systems, Inc.PXU2020-12-22
00884450486115PeriVac™ KitMerit Medical Systems, Inc.PXU2020-12-22
10884450486068Merit Medical®Merit Medical Systems, Inc.PXU2020-12-22
10884450486112Merit Medical®Merit Medical Systems, Inc.PXU2020-12-22
05708265012480LiNA OperaScope™ Tubing & Drape kitLina Medical ApSPXU2020-09-04
10888439581379CARDINAL HEALTHCardinal Health 200, LLCPXU2019-09-09
50888439581377CARDINAL HEALTHCardinal Health 200, LLCPXU2019-09-09
10888439448160CARDINAL HEALTHCardinal Health 200, LLCPXU2019-04-29
50888439448168CARDINAL HEALTHCardinal Health 200, LLCPXU2019-04-29
04046955237500ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCPXU2019-04-26