FDA.reportPublic FDA data

Regard™

Primary DI
10326053100014
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
HT0001
Published
2016-12-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
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
20326053100011PackageGS16Not in Commercial Distribution
10326053100014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605310001120326053100011
1032605310001410326053100014

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.

Regulatory Flags#

DUNS number
945020902
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
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450254677Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-29
10198956560505CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956568075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956586154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956588646CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956590052CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956610682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956611221CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956615342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618640CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956618725CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619630CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956619852CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620254CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956620261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956621336CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622418CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
10198956622425CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-29
00884450429150Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-27
10809160541814Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OEQ2026-10-27
10198956605091CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956607590CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956610873CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956620322CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-26
10198956106666CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956530157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956563063CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956590229CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956603837CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23
10198956606982CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-23