FDA.reportPublic FDA data

Regard™

Primary DI
20194717117862
Brand
Regard™
Company
ROI CPS, LLC
Model
AN01238A
Device description
IV START BLOOD COLLECTION KIT
Published
2023-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717117862PackageGS125In Commercial Distribution
10194717117865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711786220194717117862
1019471711786510194717117865

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194717102298Regard™UR00857C2019-11-21
10194717102304Regard™UR00858B2019-10-28
10194717111733Regard™GS00372E2025-03-30
10194717112488Regard™GS00237H2021-07-19
10194717112990Regard™LD01002CD2021-08-24
10194717113959Regard™GS00310D2021-11-29
10194717113973Regard™GS00311C2021-11-29
10194717114741Regard™PL00126ST2022-02-17
10194717115144Regard™HT00253H2022-03-23
10194717115175Regard™CV00256LM2022-03-23
10194717115830Regard™PL00126T2022-04-28
10194717116028Regard™ET00701GH2022-06-28
10194717116066Regard™HT00253I2022-07-14
10194717121305Regard™GS01065D2025-01-21
20194717102295Regard™UR00857C2019-11-21
10194717100355Regard™UR00279I2019-10-28
10194717100812Regard™UR00847B2019-11-14
10194717104797Regard™UR00739I2019-11-07
10194717104834Regard™UR00746G2019-10-28
10194717106609Regard™UR00746H2019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380213908Aero-MedAERO-MED, LLCOIB2026-09-25
10885380213922Aero-MedAERO-MED, LLCOIB2026-09-25
00810010894687Aero-MedAERO-MED, LLCOIB2026-09-24
00810111410533LetsGetChecked Blood and Urine Sample Collection Kit (ST04)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
10885380210891Aero-MedAERO-MED, LLCOIB2026-06-10
10885380213465Aero-MedAERO-MED, LLCOIB2026-06-10
00810057230448SNT BiotechSARIS AND THINGS, INC.OIB2026-06-04
10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
10885380212024Aero-MedAERO-MED, LLCOIB2026-06-04
10885380211768Aero-MedAERO-MED, LLCOIB2026-05-06
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10885380211218Aero-MedAERO-MED, LLCOIB2026-03-20
10192253061031Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061093Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061109Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061475Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061482Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061505Aero-MedAERO-MED, LLCOIB2026-02-20
10885380211188Aero-MedAERO-MED, LLCOIB2026-02-13
10885380210921Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210938Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210877Aero-MedAERO-MED, LLCOIB2025-12-26
10885380208935Aero-MedAERO-MED, LLCOIB2025-11-04
10885380209222Aero-MedAERO-MED, LLCOIB2025-08-26
10885380208928Aero-MedAERO-MED, LLCOIB2025-08-21
10885380208447Aero-MedAERO-MED, LLCOIB2025-06-10