FDA.report

Regard™

Primary DI
20194717102493
Brand
Regard™
Company
ROI CPS, LLC
Model
AN00007O
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
OKEPort Introducer Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717102493PackageGS110In Commercial Distribution
10194717102496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471710249320194717102493
1019471710249610194717102496

GMDN Terms

TermDefinition
Central venous catheterization kit, short-termA collection of sterile devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). 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
50198956293159CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956420708CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956424478CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956412321CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-19
50198956328134CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-10
50198956322194CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956339741CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956363531CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956401011CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956375688CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956377095CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956398625CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956336023CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359060CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359770CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956380446CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956323030CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956333992CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956344530CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956338096CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-17
50198956323115CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-13
50198956322682CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956333626CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956335200CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956356243CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956341591CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-30
50198956306118CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-23
50198956258585CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-22
00191072241610ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14
00191072241634ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14