FDA.reportPublic FDA data

Performa®

Primary DI
10884450144357
Brand
Performa®
Company
Merit Medical Systems, Inc.
Model
00884450144350
Catalog number
RADMPP-10
Published
2018-09-13
Public version status
New
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
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450144357PackageGS15In Commercial Distribution
00884450144350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445014435710884450144357
00884450144350008844501443508844501443500884450144350

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
10198956340435CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
10198956460164CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
50198956350289CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956413991CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956418101CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-23
50198956326437CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-19
50198956350920CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-16
50198956357059CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956363333CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956387872CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956334067CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956375756CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956344813CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-13
50198956020250CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956293791CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956314557CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-02
50198956258790CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
50198956316025CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
00884450306857Performa®Merit Medical Systems, Inc.OJV2026-01-29
50198956285895CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-23
50198956263008CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956300284CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956286915CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956300406CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956203011CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301212CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301823CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-13
50198956303452CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-07
50198956292831CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05
50198956305487CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05