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
00884450113059Merit Medical®Initial ReleaseK09-13911C2026-10-20
00884450840610Prelude Roadster™APG5F90S2026-10-20
00884450735916Merit Advance®AAD18N91W-E2026-10-19
10884450735906Merit Advance®AAD18N91W2026-10-19
10884450735920Merit Advance®AAD18T51W2026-10-19
10884450735944Merit Advance®AAD18T51WS2026-10-19
10884450735968Merit Advance®AAD18T71W2026-10-19
10884450735975Merit Advance®AAD18T71WC2026-10-19
10884450735999Merit Advance®AAD18T71W-E2026-10-19
10884450736033Merit Advance®AAD18T71WS2026-10-19
10884450736057Merit Advance®BAD18T71WT2026-10-19
10884450736071Merit Advance®AAD19U41W2026-10-19
10884450736118Merit Advance®AAD19U51W2026-10-19
10884450736132Merit Advance®AAD19U71W2026-10-19
10884450736149Merit Advance®AAD19U71WC2026-10-19
10884450736187Merit Advance®AAD19U71WS2026-10-19
10884450736224Merit Advance®AAD20T41W2026-10-19
10884450736262Merit Advance®AAD20T71W2026-10-19
10884450736309Merit Advance®AAD21T21W2026-10-19
10884450736361Merit Advance®AAD21T41WC2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450852279Merit Medical®Merit Medical Systems, Inc.PXU2026-09-22
00884450852286Merit Medical®Merit Medical Systems, Inc.PXU2026-09-22
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