FDA.reportPublic FDA data

H2O TORQ™

Primary DI
00884450007969
Brand
H2O TORQ™
Company
Merit Medical Systems, Inc.
Model
00884450007969
Catalog number
TD100
Published
2016-09-26
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
PTLWire, Guide, Catheter, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTLWire, Guide, Catheter, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450007966PackageGS110In Commercial Distribution
20884450007963PackageGS14In Commercial Distribution
00884450007969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445000796610884450007966
2088445000796320884450007963
00884450007969008844500079698844500079690884450007969

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.

Device Sizes#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
36927675513480RADIFOCUSTerumo Medical Products (Hangzhou) Co., Ltd.PTL2022-12-08
00860003987353Speed-Torque®Vascugenix, LLCPTL2022-11-03
00860003987360Speed-Torque®Vascugenix, LLCPTL2022-11-03
10860003987350Speed-Torque®Vascugenix, LLCPTL2022-11-03
10860003987367Speed-Torque®Vascugenix, LLCPTL2022-11-03
06947358544302Sunmed guidewire torque deviceSunny Medical Device (Shenzhen) Co., Ltd.PTL2022-01-04
00860003987315Speed Torque Vascugenix, LLCPTL2021-02-03
00860003987322Speed Torque Vascugenix, LLCPTL2021-02-03
00860003987339Speed Torque Vascugenix, LLCPTL2021-02-03
00860003987346Speed Torque Vascugenix, LLCPTL2021-02-03
00884450458068SeaDragon2™Merit Medical Systems, Inc.PTL2020-08-14
10884450458065SeaDragon2™Merit Medical Systems, Inc.PTL2020-08-14
06936733735923AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735930AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735947AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735954AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735961AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733735978AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736043AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736050AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736067AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736074AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736081AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
06936733736098AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733735937AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733735951AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733735968AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733736040AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733736064AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23
16936733736088AngiowayLepu Medical Technology (Beijing) Co.,Ltd.PTL2018-05-23