FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450037911
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
K12-03611A
Published
2026-10-17
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450037918PackageGS115In Commercial Distribution
20884450037915PackageGS14In Commercial Distribution
00884450037911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003791810884450037918
2088445003791520884450037915
00884450037911008844500379118844500379110884450037911

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
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
10884450736385Merit Advance®AAD21T41W-E2026-10-19
10884450736439Merit Advance®AAD21T71W2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956513587CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956553422CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956591677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956594395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956607712CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956608641CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956611320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613294CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956614789CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956615540CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956571495CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956599406CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956606869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956607446CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
00884450501832Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-14
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956587243CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10809160540510HALYARDAVID MEDICAL, INC.OEQ2026-10-12
10198956391215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06