FDA.report

Regard™

Primary DI
20194717101359
Brand
Regard™
Company
ROI CPS, LLC
Model
HT00907A
Published
2019-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OEQAngiography/Angioplasty Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717101359PackageGS12In Commercial Distribution
10194717101352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471710135920194717101359
1019471710135210194717101352

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117174678
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 DIBrandModelCatalogPublished
20194717102295Regard™UR00857C2019-11-21
20194717120879Regard™HT01025G2024-12-20
20194717120886Regard™LD00090U2024-12-20
20194717120893Regard™HT00074Y2024-12-20
20194717120916Regard™GS00802N2024-12-20
20194717120923Regard™OR01102D2024-12-20
20194717120930Regard™OR01103D2024-12-20
20194717120947Regard™GY013302025-01-16
20194717120954Regard™GY013312025-01-16
20194717121098Regard™GU013212025-01-16
20194717116766Regard™OR011092023-01-25
20194717116773Regard™OR011132023-01-25
20194717116780Regard™OR011112023-01-26
20194717116797Regard™OR011142023-01-27
20194717116803Regard™OR011082023-01-27
20194717116810Regard™OR011072023-01-31
20194717118715Regard™OR01103B2024-02-09
20194717118722Regard™OR01102B2024-02-13
20194717100918Regard™OR00355E2019-12-23
20194717103124Regard™OR00095U2019-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00884450220696Merit Medical®Merit Medical Systems, Inc.OEQ2026-03-24
50198956300499CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956339840CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956418514CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956421804CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956431957CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-24
50198956274721CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956325331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956332872CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956337969CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956339918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956341508CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956343342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956346541CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353211CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353488CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956359466CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956364057CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956365399CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956373110CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956400892CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956409703CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956411997CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956412154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956413526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956414707CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956415360CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956415483CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956416305CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956417937CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23