FDA.reportPublic FDA data

ReSolve®

Primary DI
10884450680107
Brand
ReSolve®
Company
Merit Medical Systems, Inc.
Model
00884450680100
Catalog number
RTT14038MB/A
Published
2022-08-05
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
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450680107PackageGS14In Commercial Distribution
00884450680100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445068010710884450680107
00884450680100008844506801008844506801000884450680100

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kitA collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603160040
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
00884450431542Merit Medical®Initial ReleaseK09-10472B2026-10-24
00884450459386MAK-NV™DMAK-NV-0182026-10-23
00884450499252Merit S-MAK™HS-MAK401N2026-10-24
10884450438777Prelude® Short SheathBPSS-7F-4MT2026-10-23
10884450834340Prelude EASE™GPHR4F11018SS2026-10-24
00884450161692Merit Medical®Initial ReleaseK09-10791D2026-10-22
00884450428238Merit Medical®Initial ReleaseK10-00125M2026-10-22
00884450435700Merit Medical®Initial ReleaseK10-04943A2026-10-22
00884450499214Merit Medical®Initial ReleaseK12T-02975G2026-10-22
00884450501023Merit Medical®Initial ReleaseK12T-127572026-10-22
00884450501047Merit Medical®Initial ReleaseK10-06118G2026-10-22
00884450501054Merit Medical®Initial ReleaseK09-05248Q2026-10-22
00884450501078Merit Medical®Initial ReleaseK10-00389R2026-10-22
00884450501085Merit Medical®Initial ReleaseK09-14184F2026-10-22
00884450502075Merit Medical®Initial ReleaseK10-03143F2026-10-22
00884450502082Merit Medical®Initial ReleaseK12T-09122J2026-10-22
00884450502556Merit Medical®Initial ReleaseK09-144532026-10-22
00884450502891Merit Medical®Initial ReleaseK09-05181J2026-10-22
00884450502921Merit Medical®Initial ReleaseK09-12476F2026-10-22
00884450502938Merit Medical®Initial ReleaseK09-14208C2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002606616OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606623OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606630OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606647OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606654OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606661OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606678OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606685OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606692OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606708OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606715OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606722OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606739OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606746OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606753OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606760OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606777OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606784OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606791OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606807OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606814OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002606821OpTUS Ultra PleuralCOOK INCORPORATEDJOL2026-10-22
00827002613553CookCOOK INCORPORATEDJOL2026-10-22
00190776436384MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436391MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436407MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436414MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436421MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436469MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436476MilleniumAvalign Technologies, Inc.JOL2026-10-08