FDA.reportPublic FDA data

Regard™

Primary DI
20326053105160
Brand
Regard™
Company
Resource Optimization & Innovation, L.L.C.
Model
303394
Published
2019-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
OFFCentral Venous Catheter Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053105163PackageGS120In Commercial Distribution
20326053105160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1032605310516310326053105163
2032605310516020326053105160

GMDN Terms#

Term, Definition table
TermDefinition
Vascular access device flush/disinfection toolA manual device intended to be used to flush wash the lumen of an in situ vascular access device (e.g., catheter, needleless intravenous line) and to disinfect the device’s Luer access valve. It consists of a prefilled syringe containing a saline solution, and a disinfection cap or scrubber containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. It may be supplied as a one-piece or modular device. This is a single-use device.

Regulatory Flags#

DUNS number
134472476
Device count
1
Premarket exempt
true
Lot or batch
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
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10193489376364Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489382747Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489409420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489411232Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489412826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489412918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489416534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489420210Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421569Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421675Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489421774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489422061Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
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10193489452396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452471Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489452846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489456028Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-06-08
10193489377194Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2023-01-01
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10193489399912Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-12-25
10193489399936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFF2022-12-25
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