FDA.reportPublic FDA data

ReSolve®

Primary DI
00884450057506
Brand
ReSolve®
Company
Merit Medical Systems, Inc.
Model
00884450057506
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450057503PackageGS15In Commercial Distribution
00884450057506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445005750310884450057503
00884450057506008844500575068844500575060884450057506

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainA flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002448Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002455Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002462Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002479Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002486Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002493Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002509Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002516Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002523Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002530Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002547Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002554Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002561Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002578Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002585Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002592Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002608Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002615Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002622Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002639Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002646Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002653Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002660Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002677Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002684Endoflux™Medi-Globe GmbHFGE2026-08-27