Regard™

Primary DI
10194717106982
Brand
Regard™
Company
ROI CPS, LLC
Model
AN01084B
Published
2020-01-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGDCustom Anesthesia Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717106989PackageGS115Not in Commercial Distribution
10194717106982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710698920194717106989
1019471710698210194717106982

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Regulatory Flags#

DUNS number
117174678
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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
10194717116219Regard™ROI CPS, LLCOGD2022-10-05
10194717115106Regard™ROI CPS, LLCOGD2022-03-22
10194717113881Regard™ROI CPS, LLCOGD2021-11-19
10195594417451CARDINAL HEALTHCardinal Health 200, LLCOGD2021-11-05
10193489361940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGD2021-08-27
10194717112761Regard™ROI CPS, LLCOGD2021-07-28
10194717110590Regard™ROI CPS, LLCOGD2021-05-10
10194717109730Regard™ROI CPS, LLCOGD2021-02-15
10194717109372Regard™ROI CPS, LLCOGD2021-01-14
10194717108924RegardROI CPS, LLCOGD2020-12-10
10194717107675Regard™ROI CPS, LLCOGD2020-06-25
10194717101222Regard™ROI CPS, LLCOGD2019-12-23
10194717103042Regard™ROI CPS, LLCOGD2019-12-10
10194717102434Regard™ROI CPS, LLCOGD2019-11-01
10326053117340Regard™Resource Optimization & Innovation, L.L.C.OGD2019-09-18
10326053114363Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2018-03-28
10326053108713Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053108737Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053100885Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-21
10326053108317Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-20
10326053107129Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-05
10809160109212AVID TruCustomAVID MEDICAL, INC.OGD2016-10-11
10809160109229AVID TruCustomAVID MEDICAL, INC.OGD2016-10-11
10809160108284AVID TruCustomAVID MEDICAL, INC.OGD2016-10-04
10809160108031AVID TruCustomAVID MEDICAL, INC.OGD2016-10-03
10809160107317AVID TruCustomAVID MEDICAL, INC.OGD2016-09-28
10809160106143AVID TruCustomAVID MEDICAL, INC.OGD2016-09-20
10809160105177AVID TruCustomAVID MEDICAL, INC.OGD2016-09-19
10809160088395AVID TruCustomAVID MEDICAL, INC.OGD2016-09-15
10809160088708AVID TruCustomAVID MEDICAL, INC.OGD2016-09-15