FDA.report

Regard™

Primary DI
20194717100253
Brand
Regard™
Company
ROI CPS, LLC
Model
GS00264E
Published
2019-11-04
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
OXQDressing Change Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20194717100253PackageGS130In Commercial Distribution
10194717100256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019471710025320194717100253
1019471710025610194717100256

GMDN Terms

TermDefinition
Wound dressing kit, medicated, sterileA collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. 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
50198956336535CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-24
50198956352887CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956352979CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956353198CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956366310CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956375367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956379686CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956381153CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956401981CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956404739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956351842CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-19
10653160392767Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392804Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392811Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392866Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392873Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
50198956348378CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
50198956351804CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
10653160392699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392705Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
50198956297478CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-10