FDA.reportPublic FDA data

Regard™

Primary DI
00326053104770
Brand
Regard™
Company
Resource Optimization & Innovation, L.L.C.
Model
303316REG
Device description
Sterle Alcohol Pads
Published
2023-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKBPad, Alcohol, Device Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKBPad, Alcohol, Device DisinfectantUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053104777PackageGS120In Commercial Distribution
00326053104770PrimaryGS10
20326053104774Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032605310477710326053104777
00326053104770003260531047703260531047700326053104770
2032605310477420326053104774

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
134472476
Device count
200
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
50192253047088WebcolCardinal Health 200, LLCLKB2025-10-16
10192253045741WebcolCardinal Health 200, LLCLKB2025-09-29
50192253045749WebcolCardinal Health 200, LLCLKB2025-09-29
10192253047073WebcolCardinal Health 200, LLCLKB2025-07-28
50192253047071WebcolCardinal Health 200, LLCLKB2025-07-28
50192253045725WebcolCardinal Health 200, LLCLKB2025-06-12
10192253045727WebcolCardinal Health 200, LLCLKB2025-06-12
10192253047066WebcolCardinal Health 200, LLCLKB2025-06-10
20192253047063WebcolCardinal Health 200, LLCLKB2025-06-10
00860000526517True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
10860000526514True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
10192253046205WebcolCardinal Health 200, LLCLKB2024-09-05
10653160373858MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00653160373851MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00310819000031Prevantics® Device Large Swab PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.LKB2024-02-15
10850049784532SURGYCOSurgyco LLCLKB2023-12-15
10850049784556SURGYCOSurgyco LLCLKB2023-12-15
20850049784539SURGYCOSurgyco LLCLKB2023-12-15
20850049784553SURGYCOSurgyco LLCLKB2023-12-15
10801741086936SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
10801741086943SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086939SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086946SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
50192253047095WebcolCardinal Health 200, LLCLKB2023-10-09
10192253047097WebcolCardinal Health 200, LLCLKB2023-10-09
06972403307571ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
06972403307564ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
00810132040788HCSConcordance Healthcare Solutions LLCLKB2023-05-01
00810132040795HCSConcordance Healthcare Solutions LLCLKB2023-05-01
10810132040785HCSConcordance Healthcare Solutions LLCLKB2023-05-01