FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450809317
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
48MMTA
Published
2024-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PYCParacentesis tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYCParacentesis TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450809317PackageGS115In Commercial Distribution
20884450809314PackageGS14In Commercial Distribution
00884450809310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445080931710884450809317
2088445080931420884450809314
00884450809310008844508093108844508093100884450809310

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain connection tubing setA device collection which includes flexible, noninvasive tubing (typically single or Y-shaped) and associated items (typically connectors, clamps, one-way valve and/or filter) intended to provide a connection between a surgical drain(s)/catheter(s) and a wound drainage container and/or suction source (the catheter, container and suction source are not included) to drain a closed wound. It is not intended to connect components of a surgical suction system (i.e., not used during general surgery). 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
true
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
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28
00884450392966SCOUT MD™Initial ReleaseMDS75M-012026-05-28
00884450428313Merit Medical®Initial ReleaseK09-09671B2026-05-28
00884450430057Merit Medical®Initial ReleaseK12-01244B2026-05-28
00884450487532Merit Medical®Initial ReleaseK09T-136472026-05-28
00884450487549Merit Medical®Initial ReleaseK12T-11710A2026-05-28
00884450487679Merit Medical®Initial ReleaseK10T-06195A2026-05-28
00884450766958Performa®B1623-F820M2026-05-28
10884450415358Prelude®JPSI-4F-23MT2026-05-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956454835CARDINAL HEALTHCardinal Health 200, LLCPYC2026-05-08
10198956400351CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
50198956400359CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
10198956303607CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
50198956303605CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
10198956196452CARDINAL HEALTHCardinal Health 200, LLCPYC2025-11-21
10198956223318CARDINAL HEALTHCardinal Health 200, LLCPYC2025-11-07
10198956179677CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
50198956179675CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
10198956100251CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
50198956100259CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
10198956082342CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
50198956082340CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
10198956056121CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
50198956056129CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
10197106886809CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
50197106886807CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
10197106914205CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
50197106914203CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
10197106881606CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
50197106881604CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
00884450809310Merit Medical®Merit Medical Systems, Inc.PYC2024-12-28
10197106793305CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
50197106793303CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
10197106471746CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
50197106471744CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
10197106569948CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12
50197106569946CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12
10197106425626CARDINAL HEALTHCardinal Health 200, LLCPYC2023-11-27
50197106425624CARDINAL HEALTHCardinal Health 200, LLCPYC2023-11-27