FDA.reportPublic FDA data

Merit Medical®

Primary DI
00884450311998
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450311998
Catalog number
BRC-BAL-INT-FL/A
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NMUNeedle, gastro-urology, reprocessed
NWUEndoscope Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NMUNeedle, Gastro-Urology, ReprocessedGeneral, Plastic Surgery1
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450311998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450311998008844503119988844503119980884450311998

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603160040
Device count
1
Premarket exempt
true
Kit
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
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956569331CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956598355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956602236CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605442CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605497CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605640CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956607743CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609723CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956612648CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10809160540756HALYARDAVID MEDICAL, INC.NWU2026-10-16
10198956565388CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956596054CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956602274CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956589810CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-13
10198956598775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-13
10198956391239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956553408CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956556522CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956564701CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956574595CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956577077CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956584150CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590793CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590809CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956592742CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956598324CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956601826CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12