FDA.reportPublic FDA data

Regard™

Primary DI
20326053113097
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
GS0860
Published
2017-05-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OXQDressing Change Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20326053113097PackageGS110Not in Commercial Distribution
10326053113090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2032605311309720326053113097
1032605311309010326053113090

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
945020902
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 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
10653160393726MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10653160393733MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10193489111224MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-08-04
10193489190106MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190113MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190120MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190151MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190397MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489112689MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-11-01
10193489112528MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112597MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112603MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112610MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112627MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112641MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112658MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112184MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112191MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112207MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112214MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112221MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112238MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112115MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112122MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112139MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112146MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112177MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489111798MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-24
10193489111804MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-24
10193489111729MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-17