FDA.reportPublic FDA data

Regard™

Primary DI
20326053105214
Brand
Regard™
Company
Resource Optimization & Innovation, L.L.C.
Model
303399
Published
2019-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEZCentral Venous Catheter Dressing Change Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053105217PackageGS120In Commercial Distribution
20326053105214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1032605310521710326053105217
2032605310521420326053105214

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
Expiration date on label
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956322349CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-29
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10198956269354CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-19
10198956236929CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-17
10198956253919CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-11-14
10198956256552CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-11-06
10198956238978CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-10-27
10197106799581CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-10-09
10198956178335CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-09-30
10198956190405CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-09-30
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